Validation Engineer

3 days ago

Chelsea, United States Disability Solutions Full time

Cleaning Validation Engineer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Cleaning Validation Engineer who is responsible for coordinating all cleaning validation and verification activities related to Drug Substance and Drug Product manufacturing, while providing adequate customer service. This person works in close collaboration with other groups such as Operations, Quality, Product Development, Engineering, and Project Management.  As an expert for the validation of cleaning processes, you are responsible for the definition and application of cleaning strategy applicable for all products/equipment of the site. This role will also support other activities, related to current operations and customers. 

This is a full time, salaried role. The core hours are Monday – Friday 8:00AM – 5:00PM

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

  • Be the site SME for the validation of cleaning process;
  • Ensure that all validations are performed according to the regulatory, site and customer requirements;
  • Integrating the production needs and ways of working in the cleaning strategy;
  • Good understanding of the production (cGMP) process;
  • Being an interface between analytical development and production + follow-up of activities on the shopfloor;
  • Communication across all departments on the cleaning strategy implementation;
  • Ensure that all activities are performed in time and with due quality;
  • Author validation and procedure documentation including, but not limited to Cleaning Validation protocols, reports, and discrepancies;
  • Investigate deviations as per need and execute corrections and/or develop preventive actions;
  • Define and execute improvement projects and initiatives to improve cleaning validation strategy and customer/site support;
  • Participate in customer and regulatory audits;
  • Can be involved in other process engineering activities;
  • All other duties as assigned

The Candidate

  • Bachelor’s degree required. Preferably in an Engineering or Scientific discipline. Master’s degree preferred;
  • Minimum three (3) years of experience in the Pharma, Medical Device or any GMP regulated environment required or an equivalent combination of education, training and experience in any GMP environment required;
  • Minimum of two (2) years’ experience in Cleaning Validation required or equivalent combination of education, training and experience required;
  • QbD experience preferred;
  • Excellent oral and written communication skills.
  • Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process 
  • Diverse, inclusive culture 
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
  • 152 Hours + 8 paid holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • Community engagement and green initiatives 
  • Generous 401K match 
  • Company match on donations to organizations
  • Medical, dental and vision benefits effective day one of employment 
  • Tuition Reimbursement – Let us help you finish your degree or start a new degree
  • WellHub program to promote overall physical wellness 
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

  • Electrical Engineer

    1 week ago

    Chelsea, United States Liberty Personnel Services, Inc Full time

    Job DescriptionJob DescriptionElectrical Engineer, PE Background designing Electrical projects using Revit 3 years of experience working for a consulting firm. Responsible for design, planning, and management of projects related to commercial, institutional, medical, and public buildings such as healthcare, biotech, higher education projectsA Bachelor’s...

  • Senior Engineer

    1 month ago

    Chelsea, United States Massachusetts Water Resources Authority Full time

    POSITION: Senior Engineer (Engineering & Construction)DIVISION: OperationsDEPARTMENT: Engineering & ConstructionUNION/GRADE: Unit 9/Grade 23TO VIEW OUR BENEFITS PLEASE CLICK ON THE LINK! - BASIC PURPOSE: With minimal supervision, manages, and performs planning, design, and construction administration services for various water and wastewater engineering...

  • zobility | Product Engineer

    5 hours ago

    Chelsea, United States zobility Full time

    Job Description:Emissions and Fuel Economy Testing Lab Hardware Engineer. Work as part of team including engineers, union technicians, and mechanics to troubleshoot and resolve test equipment issues for 9 Emissions Chassis Dynamometer test cells, 2 SHEDs, and other emissions testing equipment. Perform Quality Control and Calibration activities to satisfy...

  • Lead SCADA Systems Engineer

    1 week ago

    Chelsea, Massachusetts, United States Massachusetts Water Resources Authority Full time

    Job OverviewThe Massachusetts Water Resources Authority is seeking a highly skilled SCADA System Manager to join their team. This role will involve managing and participating in the design, development, operation, and technical support of the Authority's Water and Wastewater Supervisory Control and Data Acquisition (SCADA) systems.Key Responsibilities:Design...

  • Product Development Engineer II

    1 day ago

    Chelsea, United States Disability Solutions Full time

    Product Development Engineer II Position Summary:Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Boston-area...

  • Manager, Information Technology Security, Architecture

    1 month ago

    Chelsea, United States Massachusetts Water Resources Authority Full time

    Job DescriptionJob DescriptionDIVISION: Administration DEPARTMENT: Management Information Systems (MIS)UNION/GRADE: Non-Union/Grade 14TO VIEW OUR BENEFITS PLEASE CLICK ON THE LINK! - https://www.mwra.com/02org/html/benefits.htmBASIC PURPOSE:Plans, directs, and oversees the operations and budget of the Information Technology (IT) Security, Architecture &...

  • Senior IT Security Architect Leader

    5 days ago

    Chelsea, Massachusetts, United States Massachusetts Water Resources Authority Full time

    Job SummaryAt the Massachusetts Water Resources Authority (MWRA), we are seeking an experienced Senior IT Security Architect Leader to oversee the development, implementation, and operation of information systems and technology solutions that meet business and operational needs across our organization.About the RoleThe ideal candidate will have a Bachelor's...

  • Cisco Wireless Network Architect

    1 week ago

    Chelsea, Massachusetts, United States Saxon Global Full time

    Cisco Wireless Engineer Job SummaryAs a Cisco Wireless Engineer at Saxon Global, you will play a key role in the design, implementation, and management of wireless networks for our clients. Your expertise in Cisco wireless solutions will enable you to provide end-to-end support for wireless-related incidents, configure and support enterprise management...

  • Heavy Equipment Maintenance Specialist

    4 weeks ago

    Chelsea, Massachusetts, United States Massachusetts Water Resources Authority Full time

    Job Title: Heavy Equipment Maintenance SpecialistMassachusetts Water Resources Authority is seeking a skilled Heavy Equipment Maintenance Specialist to join our team. As a key member of our operations department, you will be responsible for the maintenance and repair of heavy equipment used in the wastewater treatment process.Key Responsibilities:Maintain...

  • Systems Analyst Manufacturing IT

    2 weeks ago

    Chelsea, United States Acorda Therapeutics Full time

    The Systems Analyst – Manufacturing IT is responsible for the translation of business problems and requirements into an information system solution following an accepted project methodology. Within this responsibility falls the analysis of an information system's requirements, design specification, project life cycle planning, project implementation,...

  • Hood Technician

    3 weeks ago

    Chelsea, United States Express Oil Change & Tire Engineers Full time

    Company Description Express Oil Change & Tire Engineers is the pre-eminent automotive maintenance provider in the nation with over 350 locations across 21 states, leading our industry through excellence, innovation, and growth. Don't let our name fool you, in addition to our fast oil change bays, our locations can be your one-stop shop with certified...

  • Project Manager, SCADA Engineering

    3 days ago

    Chelsea, MA, United States Massachusetts Water Resources Authority Full time

    BASIC PURPOSE: Manages and participates in the design, development, operation and technical support of the Authority's Water and Wastewater Supervisory Control and Data Acquisition (SCADA) systems. SUPERVISION RECEIVED: Works under the basic supervision of the Program Manager, SCADA Engineering. SUPERVISION EXERCISED: Exercises close supervision of...

  • Real Estate and Facilities Lead

    1 day ago

    Chelsea, United States Symbotic Full time

    Who we areWith its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system – reinventing warehouse automation for increased efficiency, speed and flexibility.What we need  As the Real Estate and Facilities...

  • Business Analyst

    2 weeks ago

    Chelsea, United States Compu-Vision Consulting Full time

    Job tile: Business Analyst Duration: 6 Months (Tentative) Location: Chelsea, MA(Hybrid) Summary: We are seeking a dynamic Business Analyst to join our team, focusing on our accounting software applications. The ideal candidate will be responsible for evaluating current business processes, identifying improvements, and ensuring a seamless experience for...

  • ANF Business Analyst

    2 weeks ago

    Chelsea, United States Mindlance Full time

    Job Title: Business Analyst bout the Role: We are seeking a dynamic Business Analyst to join our team, focusing on our accounting software applications. The ideal candidate will be responsible for evaluating current business processes, identifying improvements, and ensuring a seamless experience for internal users. Key Responsibilities: ct as a liaison...

  • Senior Operational Technology Network Manager

    4 days ago

    Chelsea, Massachusetts, United States Massachusetts Water Resources Authority Full time

    Job OverviewWe are seeking an experienced Senior Operational Technology Network Manager to join our team at the Massachusetts Water Resources Authority (MWRA). As a key member of our operations team, you will be responsible for managing and maintaining our large-scale enterprise network environment. This is a critical role that requires strong technical...

  • Business Analyst

    2 weeks ago

    Chelsea, United States Trillium Staffing Full time

    Trillium Professional is now seeking a Business Analyst for a hybrid schedule! We are seeking a dynamic Business Analyst to join our team, focusing on our accounting software applications. The ideal candidate will be responsible for evaluating current business processes, identifying improvements, and ensuring a seamless experience for internal users. Key...

  • Heavy Equipment Operator

    1 month ago

    Chelsea, United States Massachusetts Water Resources Authority Full time

    DIVISION: OperationsDEPARTMENT: Wastewater PipelineUNION/GRADE: Unit 3/Grade 15 TO VIEW OUR BENEFITS PLEASE CLICK ON THE LINK! - BASIC PURPOSE:Operates heavy equipment and vehicles.SUPERVISION RECEIVED: Works under the general supervision of the departmental Manager or Supervisor.SUPERVISION EXERCISED: Exercises close supervision of skilled laborers and...

  • Strategic Business Solutions Professional

    2 weeks ago

    Chelsea, Massachusetts, United States Compu-Vision Consulting Full time

    **Compu-Vision Consulting: Business Analyst Position**As a Business Analyst at Compu-Vision Consulting, you will be responsible for evaluating current business processes and identifying areas for improvement. Your focus will be on our accounting software applications, ensuring a seamless experience for internal users.**Key Responsibilities:**Act as a liaison...

  • Technical Support Technician II

    3 weeks ago

    Chelsea, United States Massachusetts Water Resources Authority Full time

    BASIC PURPOSE: Configures, tests, and installs computer hardware, software and related peripheral products for MWRA staff. Provides Tier 1 and Tier 2 technical support, including troubleshooting hardware, software, and peripheral problems. Assists with the evaluation, testing and certification of new and emerging computer technology products. Assists MWRA...