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Lead Quality Validation Engineer

Employer
Thermo Fisher Scientific
Location
Cambridge, MA
Closing date
Sep 17, 2021

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Sector
Science, Physical Sciences and Engineering
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When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Thermo Fisher Scientific Viral Vector Services (VVS), is a rapidly growing, dynamic gene therapy contract development and manufacturing organization. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

What will you do?
  • Provide senior level support of the QA Validation functions.
  • Provide quality oversight of facility/utility and equipment for qualification activities.
  • Review of all documents such as URS, DQ, SAT, FAT, design documents, Qualification protocols (IQ, OQ &PPQ) generated for the qualification and validation of equipment and systems.
  • Carry out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EU.
  • Comply with all client site policies and procedures.
  • Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements necessary to maintain a validated status.
  • Support sterilization validation efforts.
  • Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
  • Support review and approval of generation of quality assurance policies and procedures
  • Support interpret and implement quality assurance standards
  • Subject matter Expert responsible for maintaining change control system. Provide QAV support and assessments on change controls. Review for execution approval of change controls per change control SOP and client agreement.
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Review equipment and automation qualification and validation protocols
  • Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data


How will you get here?

Education:
  • Bachelor's degree in sciences/ Engineering with 4-6 years of industry related experience desired, high school diploma/GED with 12 years of industry related experience is minimum requirement


Experience:
  • Minimum 4-6 years industry related experience.
  • Minimum 4-6 years of direct GMP experience.
  • Must have strong knowledge of 21 CFR, ICH Q9 & ICH Q10, and EU regulations, GAMP, ASTM-E2500.
  • Must have strong understanding of QBD, risk Based, and performing Quality Risk Assessments
  • Must be able to understand operational documents for GMP compliance, accuracy and completeness
  • Quality inspection, auditing and testing experience
  • Experience with implementation of corrective action programs


Knowledge, Skills, Abilities:
  • Strong computer skills including Microsoft Office, QA applications and databases
  • Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
  • Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (PROCESS, SAFETY, PERSONNEL) AREA MANAGEMENT.
  • Ability to function in a dynamic environment and balance multiple priorities simultaneously
  • Ability to learn new software tools quickly
  • Ability to make decisions with minimal to moderate supervision
  • Ability to aseptically gown and /or sterile gown as needed


At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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