![Merck](https://media.trabajo.org/img/noimg.jpg)
Specialist, Validation
4 weeks ago
Job Description
GENERAL INFORMATION
We have an exciting opportunity for a Validation Specialist to join the technical operations team for a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, component preparation areas, harvest, filling, lyophilization, product inspection, and quality control laboratories. The Validation Specialist is responsible for providing technical support to one of the vaccine manufacturing areas.
POSITION OVERVIEW
The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting FAT, IQ and OQ while specifically providing cycle development and Performance Qualification (PQ) for equipment and systems supporting the Drug substance and Drug Product areas. The Validation Specialist will primarily support the drug substance and drug product site readiness via Validation program implementation, partnering with cross-functional teams (i.e. Maintenance, Global Engineering, Quality, and Operations) to ensure a successful technology transfer, filing, and licensure for a new Bladder Cancer drug substance and drug product manufacturing facility.
Additionally, this role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required at times based on business unit needs and specific assignments.
Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities may include but are not limited to:
- Provide validation support for commercial technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance, key intermediates e.g., media and cleaning solutions, component prep (Autoclave and Parts Washer) and drug product e.g., vial washing, depyrogenation, filling, lyophilization.
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
- Lead validation studies and author the associated documentation
- Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
- Collaborate with internal/external partners, e.g. Other of our Company sites, Procurement, Raw Material & Component Suppliers
- Author, review, and/or edit validation documents to support regulatory filings
- Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
- Lead validation topics in regulatory inspections by presenting and defending validation documentation.
- Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation.
- Participate in the feasibility activities working alongside Operation's team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
- Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.
- Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions.
- Provide contributions to the planning, design, and implementation of segments of new facilities, systems and equipment in a cost effective and timely manner.
- Design validation studies, author and approve protocols, and ensure alignment with corporate standards and site guidance for validation.
- Author or update Validation SOPs
- Assist in authoring the regulatory submission for the facility and present your work to multiple regulatory agencies throughout the pre-approval inspection processes.
- Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause.
- Maintain alignment with internal Technical personnel regarding validation practices for products, processes, and equipment.
- Partner with Operations, Quality, and Automation functional areas on validation study implementation.
Education Minimum Requirement:
- Bachelor of Science Degree in Engineering or Life Sciences with a minimum of two (2) years of relevant experience.
Required Experience and Skills:
- Experience in pharmaceutical manufacturing within a cGMP environment
- Experience authoring technical documentation within a cGMP context
- Outstanding communication (written & presentation) skills
- Demonstrated effective written and verbal communication skills
- Experience with project strategic plan development and management
- Demonstrated ability to work both independently and as a part of a team
Preferred Experience and Skills:
- Experience with facility, equipment, and process start-up in a sterile GMP environment.
- Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens, VHP)
- Cleaning validation (CIP, COP)
- Controlled Temperature Units (Refrigerators, Freezers, Incubators)
- Validation experience in support of GMP process demonstration (IQ/OQ/PQ)
- Air Visualization Studies (Smoke Studies)
- Sustaining the validated state through change management and continuing validation studies
- Strong technical problem-solving abilities
- Experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA)
- Experience with face to face presentation of technically complex subjects to regulatory inspectors
- The ability to work well under pressure and achieve results within tight deadlines
Travel: Up to 20% of the time
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/22/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/22/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R307878
-
Validation Specialist
15 hours ago
Durham, North Carolina, United States DPS Group LLC Full timeAbout the RoleWe are seeking a highly skilled Validation Specialist to join our team at DPS Group LLC. As a key member of our team, you will be responsible for ensuring the quality and integrity of our projects.Key ResponsibilitiesProvide support for Commissioning and Qualification activities for our clientsAuthor and execute Commissioning and Qualification...
-
Manufacturing Validation Specialist
1 week ago
Durham, North Carolina, United States Katalyst Healthcares and Life Sciences Full timePosition Overview: Join Katalyst Healthcares and Life Sciences as a Process/Validation Engineer, where you will play a crucial role in ensuring the integrity and compliance of our manufacturing processes.Key Responsibilities:Validation Strategy Development: Formulate and execute validation strategies for processes, equipment, and cleaning protocols, adhering...
-
Validation Area Specialist
1 month ago
Durham, North Carolina, United States Novo Nordisk Full timeAbout the DepartmentFor more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In...
-
Validation Specialist
15 hours ago
Durham, North Carolina, United States Verista Full timeAbout VeristaVerista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with top brands to empower growth and innovation within the scientific community.Job SummaryWe are seeking a highly skilled Validation Engineer - Quality Assurance Specialist to join our team. As a key member of our...
-
CQV Validation Specialist
1 week ago
Durham, North Carolina, United States Verista Full timeAbout Verista: Verista's team of 600 experts collaborates with some of the most recognized names in the life sciences sector to address their operational challenges. Our mission is to foster growth and innovation within the scientific community, assisting researchers, organizations, and companies in tackling significant healthcare issues. We offer...
-
Quality Assurance Validation Specialist
1 week ago
Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full timePosition Overview: As a Validation Engineer at MedPharm, you will play a crucial role in delivering validation support for pharmaceutical development and manufacturing processes. This position requires meticulous execution of validation tasks and thorough documentation to ensure compliance with industry standards. Core Responsibilities: Site Master...
-
Procurement Specialist
4 days ago
Durham, North Carolina, United States A-Line Staffing Solutions Full timeJob OverviewWe are currently in search of a Procurement Specialist who will be tasked with managing commodities or assignments that necessitate the application of fundamental purchasing principles, theories, and concepts. The Procurement Specialist plays a crucial role in ensuring the timely acquisition of products or services from established sources of...
-
Pipefitting Specialist
1 week ago
Durham, North Carolina, United States NearU Full timeJoin Our Team - Pipefitting Specialists WantedNearU is seeking skilled Pipefitting Specialists to enhance our workforce. As part of our dedicated team, you will benefit from competitive compensation, comprehensive benefits, and ample opportunities for professional advancement.What We Offer:A collaborative and encouraging workplace cultureTailored career...
-
Environmental Health Services Specialist
9 hours ago
Durham, North Carolina, United States Durham County Full timeJob SummaryWe are seeking a highly skilled Environmental Health Program Specialist to join our team at Durham County. The successful candidate will be responsible for enforcing state rules and statutes related to on-site wastewater systems, conducting site evaluations, and ensuring compliance with all applicable laws and regulations.Key...
-
Delivery Specialist
4 days ago
Durham, North Carolina, United States Brame Specialty CO Full timeJob SummaryWe are seeking a skilled Delivery Specialist to join our team at Brame Specialty CO. As a key member of our logistics team, you will be responsible for efficiently delivering products to our customers via a 26FT box truck, Monday through Friday.Key ResponsibilitiesRoute Management: Manage delivery routes that include multiple customers and...
-
Automotive Repair Specialist
1 week ago
Durham, North Carolina, United States AAMCO Transmissions Inc Full timeAs an Automotive Repair Specialist, you will be tasked with addressing a wide array of vehicle maintenance challenges and swiftly diagnosing performance issues.Key Responsibilities:Examine, identify, and rectify automotive system malfunctionsRemove and reinstall transmission assembliesSupport fellow technicians in executing technical tasksCommunicate issues...
-
On-Site Wastewater Management Specialist
3 days ago
Durham, North Carolina, United States Durham County Full timeJOB DESCRIPTION: Key Responsibilities: Ensure adherence to state regulations and laws concerning on-site wastewater management systems. Perform comprehensive site assessments and authorize permits. Oversee the performance of existing systems and conduct inspections of new installations. Keep accurate records and documentation of all activities undertaken....
-
On-Site Wastewater Management Specialist
1 week ago
Durham, North Carolina, United States Durham County Full timeJOB DESCRIPTION: Key Responsibilities: Implement state regulations and guidelines pertaining to on-site wastewater management systems. Perform site assessments and grant necessary permits. Oversee the monitoring of existing systems and conduct inspections of new installations. Keep accurate records and documentation of all activities. Execute additional...
-
HVAC Maintenance Specialist
3 days ago
Durham, North Carolina, United States Lula Full timeJob OverviewLula is seeking a 1099 HVAC Maintenance Specialist to assist with the upkeep of numerous rental properties. We are looking for candidates with a background in property management who exhibit a proactive and enthusiastic approach. The ideal candidate must demonstrate reliability, possess excellent communication abilities, be technologically savvy,...
-
HVAC Maintenance Specialist
1 week ago
Durham, North Carolina, United States Lula Full timeJob OverviewLula is seeking a 1099 HVAC Maintenance Specialist to assist with the upkeep of numerous rental properties. We are looking for candidates with a background in property management who demonstrate a proactive approach to their work. The ideal candidate should be reliable, possess excellent communication abilities, be tech-savvy, and excel in...
-
Automotive Body Repair Specialist
1 week ago
Durham, North Carolina, United States Michael Jordan Nissan Full timeJob OverviewJoin the skilled team at Michael Jordan Nissan as a full-time Automotive Body Repair Specialist. This position offers an exciting opportunity to blend your passion for automotive repair with competitive compensation and benefits.We provide career advancement opportunities, competitive pay ranging from $20 to $26 per hour, and comprehensive...
-
Automotive Collision Repair Specialist
1 week ago
Durham, North Carolina, United States EmergencyMD Full timeElevate your career as a full-time Automotive Collision Repair Specialist at EmergencyMD. Are you prepared to immerse yourself in the dynamic field of auto body repair? Join our team and become part of a successful organization where your expertise is valued and your commitment to quality is the cornerstone of our operations.This role offers competitive...
-
Residential Habilitation Specialist
1 week ago
Durham, North Carolina, United States Changing Lives residential care Full timePosition OverviewWe are seeking a dedicated Residential Habilitation Specialist to provide support in a group home environment. This role is essential in assisting individuals with daily living activities in a nurturing setting.Key ResponsibilitiesAssist clients with daily living tasks (ADLs) including cooking, cleaning, and transportation.Support clients in...
-
HVAC Maintenance Specialist
3 days ago
Durham, North Carolina, United States Lula Full timeJob OverviewLula is in search of a 1099 HVAC Maintenance Specialist to assist with the upkeep of numerous rental properties. We are looking for candidates with a background in property management who demonstrate a proactive attitude. The ideal candidate must be reliable, possess excellent communication skills, be tech-savvy, and excel in problem-solving....
-
Fiber Installation Specialist
22 hours ago
Durham, North Carolina, United States Kanaan Communications, LLC Full timeAbout the RoleWe are seeking a skilled Fiber Installation Specialist to join our team at Kanaan Communications, LLC. As a Fiber Installation Specialist, you will play a critical role in connecting America by troubleshooting and repairing OSP buried drops, splicing fiber optic cable, and performing restoration after digging.Key ResponsibilitiesTroubleshoot...