Current jobs related to Senior Validation Engineer - Arcadia, California - Theragent Inc

  • Senior Substation Electrical Engineer

    4 weeks ago

    Arcadia, California, United States West Power Energy Full time

    Job Title: Senior Substation EngineerWest Power Energy is a leading engineering consulting firm specializing in power generation, transmission, and distribution. We are seeking an experienced Senior Substation Engineer to join our team.Job Summary:We are looking for a seasoned Substation Engineer with 6-8 years of combined experience in the design of...

  • Senior Design Manager

    3 weeks ago

    Arcadia, California, United States CMTS Full time

    Senior Design ManagerCMTS is seeking a highly experienced Senior Design Manager to lead our design team in Los Angeles, CA.Key Responsibilities:Plan, organize, and direct the design activities for the School Upgrade Program and critical repair projects.Function as the lead design professional in the Design Department, providing quality review, implementation...

  • Senior Recruiter

    1 month ago

    Arcadia, California, United States Din Tai Fung Full time

    About the RoleWe are seeking a highly skilled Senior Recruiter to join our team at Din Tai Fung. As a Senior Recruiter, you will be responsible for managing the full recruitment workflow, advising our business on corporate-level hiring, and mentoring the talent acquisition team.Key ResponsibilitiesRecruitment: Collaborate with department leaders to identify...

  • Senior Design Manager

    1 week ago

    Arcadia, California, United States Kitchell Full time

    About the RoleKitchell seeks an experienced Senior Design Manager to join our team in Los Angeles. As an employee-owned company, we offer a unique opportunity for growth and financial stability.Key ResponsibilitiesManage multiple projects, including seismic, critical repair, and retrofit projects. Supervise a team of design professionals and other...

  • Senior Design Manager

    4 weeks ago

    Arcadia, California, United States Kitchell Full time

    About the RoleKitchell is seeking an experienced Senior Design Manager to join our Southern California region in Los Angeles. As an employee-owned company, we offer a unique opportunity to build a long-term career and participate in profit sharing.Key ResponsibilitiesManage multiple projects with a focus on seismic, critical repair, and retrofit...

  • Senior Design Manager

    3 weeks ago

    Arcadia, California, United States Kitchell Full time

    About the RoleKitchell is seeking an experienced Senior Design Manager to join our Southern California region in Los Angeles. As an employee-owned company, we offer a unique opportunity for professionals to build a long-term career and participate in profit sharing.Key ResponsibilitiesManage multiple projects with a focus on seismic, critical repair, and...

  • Senior Public Health Nutritionist Supervisor

    2 weeks ago

    Arcadia, California, United States My Florida Corp Defunct Full time

    Job Title: Senior Public Health Nutritionist SupervisorThis is a challenging and rewarding role that requires a strong background in public health nutrition and leadership skills. As a Senior Public Health Nutritionist Supervisor, you will oversee the Women, Infants, and Children (WIC) program at the DeSoto County Health Department, ensuring that it is...

  • Senior Design Manager

    1 week ago

    Arcadia, California, United States CMTS Full time

    About the Role:CMTS is seeking a highly motivated Senior Design Manager to lead our facilities design process. As a key member of our team, you will be responsible for managing multiple projects, including engineering repair and critical repair, through interaction with Architects, consultants, and District personnel.Key Responsibilities:Manage the design...

  • Senior Public Health Nutritionist Supervisor

    3 weeks ago

    Arcadia, California, United States My Florida Corp Defunct Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Public Health Nutritionist Supervisor to join our team at the Florida Department of Health in DeSoto County. As a key member of our team, you will be responsible for overseeing the Women, Infants, and Children (WIC) program, providing nutrition assessment and counseling to WIC participants,...

  • Senior Public Health Nutritionist Supervisor

    4 weeks ago

    Arcadia, California, United States My Florida Corp Defunct Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Public Health Nutritionist Supervisor to join our team at the Florida Department of Health in DeSoto County. As a key member of our team, you will be responsible for overseeing the Women, Infants, and Children (WIC) program, providing nutrition assessment and counseling to WIC participants,...

  • Senior Public Health Nutritionist Supervisor

    4 weeks ago

    Arcadia, California, United States My Florida Corp Defunct Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Public Health Nutritionist Supervisor to join our team at the Florida Department of Health in DeSoto County. As a key member of our team, you will be responsible for overseeing the Women, Infants, and Children (WIC) program, providing nutrition assessment and counseling to WIC participants,...

  • Automotive Mechanic

    4 weeks ago

    Arcadia, California, United States Griess Automotive Full time

    Automotive Technician Job DescriptionGriess Automotive is seeking a skilled and experienced Automotive Technician to join our team. As a key member of our team, you will be responsible for performing routine automotive maintenance tasks, diagnosing and repairing vehicle systems, and providing exceptional customer service.Responsibilities:Perform routine...

  • Automotive Repair Specialist

    2 weeks ago

    Arcadia, California, United States Griess Automotive Full time

    Job Title: Automotive Technician/MechanicAt Griess Automotive, we are seeking a skilled and experienced Automotive Technician to join our team. As a key member of our team, you will be responsible for delivering high-quality service to our customers, ensuring their vehicles are in top condition.Responsibilities:Perform routine automotive maintenance tasks,...

  • Substation Electrician

    2 weeks ago

    Arcadia, California, United States Powerserve Technologies Full time

    Job DescriptionWe are seeking experienced high voltage Substation Electricians/Technicians to join our team. As a key member of our crew, you will perform structural and electrical work inside high voltage substations, learning to install steel structures, porcelain insulators, high voltage equipment, and assembly of high voltage gang-operated switches. You...

  • Firefighter Paramedic

    2 weeks ago

    Arcadia, California, United States City of Arcadia, CA Full time

    Job SummaryWe are seeking a highly skilled Firefighter Paramedic to join our team at the City of Arcadia, CA. As a Firefighter Paramedic, you will be responsible for responding to emergency medical calls, providing advanced life support, and participating in fire prevention and suppression activities.Key ResponsibilitiesRespond to emergency medical calls and...

  • Firefighter Paramedic

    3 weeks ago

    Arcadia, California, United States City of Arcadia, CA Full time

    Job Title: Firefighter ParamedicWe are seeking a highly skilled and dedicated Firefighter Paramedic to join our team at the City of Arcadia, CA. As a Firefighter Paramedic, you will be responsible for responding to emergency medical calls, providing advanced life support, and participating in fire prevention and suppression activities.Key...

  • Firefighter Paramedic Specialist

    2 weeks ago

    Arcadia, California, United States City of Arcadia, CA Full time

    Job SummaryWe are seeking a highly skilled Firefighter Paramedic to join our team at the City of Arcadia, CA. As a Firefighter Paramedic, you will be responsible for providing emergency medical services, fire protection, and prevention services to the community.Key ResponsibilitiesRespond to medical and trauma emergencies, providing advanced life support...

  • Mechanical Engineer

    7 days ago

    Arcadia, United States GCR Professional Services Full time

    Job Description: Mechanical Engineer We are seeking an experienced Mechanical Engineer to lead the design and supervise the construction of plants/facilities Key Responsibilities: Design and oversee the mechanical aspects ofplant construction. Collaborate with drafters and designers; manage CAD/design software activities (AutoCAD, SolidWorks). Perform...

  • Mechanical Engineer

    5 days ago

    Arcadia, United States GCR Professional Services Full time

    Job Description: Mechanical EngineerDo you have the following skills, experience and drive to succeed in this role Find out below.We are seeking an experienced Mechanical Engineer to lead the design and supervise the construction of plants/facilitiesKey Responsibilities: Design and oversee the mechanical aspects ofplant construction. Collaborate with...

  • Small Engine Technician

    2 weeks ago

    Arcadia, Florida, United States EarthBalance Corp Full time

    Job SummaryEarthBalance Corp is seeking a skilled Small Engine Technician to join our team. As a Small Engine Technician, you will be responsible for diagnosing, repairing, and overhauling small engines used to power pole saws, chainsaws, recreational vehicles, and other related equipment.Key ResponsibilitiesDiagnose and repair small engines used in various...

  • Correctional Probation Senior Officer

    3 weeks ago

    Arcadia, Florida, United States My Florida Corp Defunct Full time

    Job SummaryWe are seeking a highly skilled and experienced Correctional Probation Senior Officer to join our team at My Florida Corp Defunct. As a key member of our organization, you will be responsible for supervising and monitoring a caseload of offenders, providing guidance and support to ensure compliance with supervision orders.Key...

  • Senior Full Stack Python Engineer

    1 day ago

    Arcadia, United States Centerfield Corporation Full time

    Hi, We're Centerfield Super-powered customer acquisition. Centerfield delivers outcome-based digital marketing solutions and personalized omnichannel experiences for the world’s leading brands. Powered by our proprietary Dugout platform, Centerfield acquires customers at scale for leading residential service, insurance, e-commerce, and B2B brands....

  • Agricultural Equipment Operators

    2 weeks ago

    Arcadia, Ohio, United States United Parcel Service Full time

    Shift Your World with UPS as a Tractor Trailer Driver. As a key part of our operations, you'll drive a tractor trailer from one UPS location to another or to a customer on an established route. With a valid CDL license and a love of truck driving, you'll be part of a strong national team. What does it take? Valid CDL license in home state Doubles/Triples...

  • Correctional Probation Officer

    4 weeks ago

    Arcadia, Florida, United States State of Florida Full time

    Job SummaryThe State of Florida is seeking a highly skilled Correctional Probation Senior Officer to join our team. As a key member of our department, you will be responsible for supervising and monitoring a caseload of offenders, ensuring their compliance with supervision orders and providing guidance and support as needed.Key ResponsibilitiesSupervise and...

  • Agricultural Equipment Technician

    1 week ago

    Arcadia, Florida, United States Bethel Farms LLLP Full time

    Job Title: Mobile Diesel MechanicAgricultural Equipment TechnicianBethel Farms LLLP is seeking a skilled Mobile Diesel Mechanic to join our team. As a Mobile Diesel Mechanic, you will be responsible for troubleshooting and ensuring the functionality and reliability of agricultural equipment, vehicles, engines, and mechanical systems.Key...

  • Automotive Technician/Mechanic

    2 months ago

    Arcadia, United States Griess Automotive Full time $20 - $35

    SIGN ON BONUS AND  REOLCATION ASSISTANCEMonday - Friday 8-5.No weekends.Air conditioned shop.Paid time off and holidays.401k match.Pay and Bonus is based on experience.Small town, low stress work environment.Low cost of living.Company Overview: Join our team at Griess Automotive, a leading automotive service provider dedicated to delivering top-notch...

  • Diesel Mechanic

    3 weeks ago

    Arcadia, Wisconsin, United States Nuss Truck & Equipment Full time

    Diesel Mechanic Job DescriptionNuss Truck & Equipment, the 2017 American Truck Dealer of the Year, is seeking a skilled Diesel Mechanic to join our team. As a leading provider of OTR and vocational trucks, combined with world-class Volvo Construction Equipment, we offer a competitive benefits package and generous hiring bonus.Responsibilities:Repair,...

  • Tractor Trailer Driver

    4 weeks ago

    Arcadia, United States United Parcel Service Full time

    SHIFT YOUR WORLD Full Time Tractor Trailer Driver SHIFT YOUR TEAM Who exactly are UPS Tractor Trailer Drivers? First and foremost, they’re part of one strong, national team and are a key part of our operations. We refer to them as Feeder Drivers. They drive a tractor trailer from one UPS location to another—or to a customer on an established...

  • Internet Sales Consultant | Mercedes-Benz Arcadia

    5 months ago

    Arcadia, United States Rusnak Full time

    Overview Are you ready to make the next move for your career? Do you have a passion for luxury cars? We are HIRING and we want to hear from you! JOIN OUR TEAM Rusnak Auto Group is a leader in the automotive industry with a stellar reputation in the Greater Los Angeles and throughout Southern California. Our commitment to serve our customers and...

  • Diesel Mechanic

    3 weeks ago

    Arcadia, Wisconsin, United States Nuss Truck & Equipment Full time

    Diesel Mechanic Job DescriptionNuss Truck & Equipment, the 2017 American Truck Dealer of the Year, is seeking a skilled Diesel Mechanic to join our team. As a Diesel Mechanic, you will be responsible for performing repairs and diagnostics on heavy-duty trucks and construction equipment at our Eau Claire, Wisconsin location.Responsibilities:Repair, overhaul,...

  • Seasonal Package Delivery Driver

    2 weeks ago

    Arcadia, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Casual Package Deliver Driver SHIFT YOUR TEAM Who exactly are casual UPS Package Delivery Drivers? They’re the ones who drive our familiar brown trucks, bringing packages great and small to our customers. They’re a friendly, physically active crew who enjoy fast-paced work, being outdoors, and being behind the wheel! SHIFT YOUR...

  • Tractor Trailer Driver

    2 weeks ago

    Arcadia, United States United Parcel Service Full time

    SHIFT YOUR WORLDFull Time Tractor Trailer DriverSHIFT YOUR TEAMWho exactly are UPS Tractor Trailer Drivers?First and foremost, they’re part of one strong, national team and are a key part of our operations. We refer to them as Feeder Drivers. They drive a tractor trailer from one UPS location to another—or to a customer on an established route—before...

  • Seasonal Package Delivery Driver

    3 weeks ago

    ARCADIA, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Casual Package Deliver Driver SHIFT YOUR TEAM Who exactly are casual UPS Package Delivery Drivers? They’re the ones who drive our familiar brown trucks, bringing packages great and small to our customers. They’re a friendly, physically active crew who enjoy fast-paced work, being outdoors, and being behind the wheel! SHIFT...

  • Seasonal Package Delivery Driver

    3 weeks ago

    Arcadia, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Casual Package Deliver Driver SHIFT YOUR TEAM Who exactly are casual UPS Package Delivery Drivers? They’re the ones who drive our familiar brown trucks, bringing packages great and small to our customers. They’re a friendly, physically active crew who enjoy fast-paced work, being outdoors, and being behind the wheel! SHIFT YOUR...

  • Seasonal Package Delivery Driver

    3 weeks ago

    Arcadia, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Casual Package Deliver Driver SHIFT YOUR TEAM Who exactly are casual UPS Package Delivery Drivers? They’re the ones who drive our familiar brown trucks, bringing packages great and small to our customers. They’re a friendly, physically active crew who enjoy fast-paced work, being outdoors, and being behind the wheel! ...

  • Correctional Probation Officer

    4 weeks ago

    Arcadia, FL, United States My Florida Corp Defunct Full time

    Job SummaryWe are seeking a highly skilled Correctional Probation Senior Officer to join our team at My Florida Corp Defunct. As a Correctional Probation Senior Officer, you will be responsible for supervising and monitoring a caseload of offenders, conducting field and office visits, and providing guidance and support to help offenders comply with their...

  • Human Resources Manager, Talent Acquisition

    2 days ago

    Arcadia, United States LA Family Housing Full time

    POSITION: Human Resources Manager – Talent Acquisition & Onboarding DIVISION: Human Resources LOCATION: North Hollywood, CA HIRING RATE: $84,092/ annual WHY JOIN US: You believe that every person deserves a place to call home. You see that homelessness is a systemic issue and want to be a part of the solution. You are ready to utilize your talent,...

Senior Validation Engineer

2 months ago

Arcadia, California, United States Theragent Inc Full time
Job Overview

Position Summary:

Theragent is in search of a dedicated Senior Validation Engineer to spearhead and assist in validation, business analysis, and operational excellence initiatives aimed at establishing a CGMP facility for cell and gene therapy.

The individual in this position will receive training to manage and support the execution and validation of projects with moderate to high complexity (including equipment, utilities, facilities, processes, computerized systems, temperature mapping, etc.). Responsibilities will encompass requirements gathering, engineering studies, determining validation strategies, generating and reviewing documentation (such as specifications, protocols, risk assessments, etc.), and executing tasks in collaboration with both internal teams and validation contractors. This role will also involve overseeing contractors and serving as the validation signatory representative, responsible for reviewing and approving validation lifecycle documentation for GMP compliance, while being accountable to Theragent management and regulatory bodies.

Moreover, this multifaceted role will engage in Business Analysis and Operational Excellence efforts, concentrating on collecting business and workflow requirements, facilitating discussions between business stakeholders and technical teams, proposing feasible technical solutions and workflows, and identifying opportunities to enhance business operations for improved efficiency while ensuring compliance. With guidance from the team, this position will contribute to the establishment and advancement of all aspects of the validation, business analysis, and operational excellence programs necessary for maintaining and optimizing the Theragent CGMP facility for cell and gene therapy. This role presents exciting professional development opportunities within a rapidly growing organization.

The ideal candidate will possess a robust understanding of the validation lifecycle and quality systems, experience with lean methodologies, and the ability to quickly adapt to new technologies while being flexible to accommodate changing priorities in a dynamic startup environment.

Work Arrangement: This position can be either part-time or full-time on a contract basis, with the potential for conversion to a permanent role based on performance and business requirements.

Key Responsibilities:

  • Qualification and Validation:
    1. Lead and support GMP validation projects of moderate to high complexity (including equipment, instruments, computerized systems, utilities, facilities, processes, temperature mapping, etc.) in collaboration with in-house and contracted resources.
    2. Facilitate the requirements gathering process and assist in the implementation, integration, and risk-based qualification of IT systems and software for CGMP use, necessitating proficient knowledge of SDLC, data integrity, and system integrations.
    3. As needed, create qualification and validation lifecycle documents (requirements, risk assessments, protocols, etc.), conduct the associated studies, analyze the resulting data, and prepare the final report.
    4. Act as the Validation Subject Matter Expert (SME) for validation project scopes, methodologies, and justifications.
    5. Develop Standard Operating Procedures to enhance and mature the Theragent Validation program.
    6. Assist in validation deviation investigations and identify assignable causes in collaboration with the Validation Lead and contractors.
    7. Review validation lifecycle documentation, including requirements, specifications, protocols, and reports.
    8. Serve as the validation signatory representative to approve validation documentation, accountable to Theragent management and regulatory agencies.
    9. Support the Validation Team in any necessary activities to aid in the development, execution, or enhancement of the Theragent Validation program.
    10. Comprehend the application of Data Integrity per 21 CFR Part 11.
    11. Possess experience and familiarity with FDA, GLP, QSR, and CGMP regulations.
  • Business Analysis and Operational Excellence:
    1. Champion the adoption of new technologies and systems to fulfill business needs.
    2. Conduct interviews and workshops to gather business and workflow requirements, producing detailed specifications and process documentation.
    3. Collaborate with IT and other departments to design viable solutions, develop test plans, and organize user acceptance testing (UAT).
    4. Drive and enhance results by utilizing lean tools (such as value stream mapping, DMAIC methodology, etc.), consulting skills, and change management processes, taking responsibility for implementing lean initiatives within organizational value streams.
    5. Define KPIs, metrics, and continuous improvement objectives within the organization to advance business goals in development and manufacturing services.
    6. Work with management to identify major opportunities for throughput improvement to optimize organizational and business efficiency.

Reports to: Associate Director, Validation & Operational Excellence

FLSA Status: Exempt

Knowledge, Skills & Abilities:

  • Extensive knowledge of computer system validation (CSV) for software applications.
  • Experience in equipment qualification within a CGMP environment (IQ, OQ, PQ). Experience with cell therapy equipment qualification is advantageous.
  • Strong grasp of the validation lifecycle in GMP settings.
  • Familiarity with Computerized Systems SDLC and data integrity principles.
  • Knowledge of CGMP, GAMP, 21CFR part 11, and GDP.
  • Understanding of pharmaceutical, manufacturing, and laboratory systems and equipment.
  • Experience with lean methodologies is beneficial.
  • Excellent interpersonal skills with experience engaging with a diverse workforce.
  • Proven organizational skills with the ability to manage multiple tasks in a fast-paced environment.
  • Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook.
  • Ability to quickly grasp and learn new technologies.
  • Creative problem-solving skills, with the ability to think outside the box for solutions.
  • Self-motivated and capable of working independently with minimal supervision.
  • Proactive, results-oriented, and detail-oriented.
  • Strong written and verbal communication skills, including technical writing abilities.
  • A collaborative team player, able to meet deadlines and adapt to changing priorities.
  • Understanding of CGMP regulations, particularly in the context of cell and gene therapy, is a plus.

Education & Professional Experience:

  • A minimum of 4-6+ years of relevant experience in Validation, Business Analysis, and/or Operational Excellence within the Pharmaceutical or Life Sciences industry in a CGMP environment.
  • A Bachelor's degree in a science-related field, preferably in Life Sciences or Engineering. An advanced degree is a plus.
  • A strong background in computer system validation (CSV) is essential.
  • Six Sigma certification is advantageous.

Working Conditions:

  • Primarily an office environment, with occasional requirements to enter GMP laboratory or manufacturing areas while adhering to proper gowning/lab coat or PPE protocols.
  • Must be able to read, write, and converse in English.
  • Occasional physical activities including stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25lbs.
  • Ability to sit, stand, walk, and move within the workspace for extended periods.
  • Capability to perform repetitive tasks involving hand and finger manipulations, grasping, pushing, and pulling.
  • Ability to work safely and effectively both independently and collaboratively.

Travel: Occasional travel may be required, less than 10%.

This description outlines the fundamental responsibilities and requirements for the noted position. It is not an exhaustive listing of all job duties associated with the role. Duties, responsibilities, and activities may change at any time with or without notice.

Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidates must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief or practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.