Job Title: CQV Engineer II

Location: Carlsbad, CA

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or improving efficiencies in their laboratories, we are here to support them.

Location/Division Specific Information

At Microbial Manufacturing Services (MMS), a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and ground breaking Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

How will you make an impact?

The CQV Engineer II is part of a professional support staff working under the guidance of the CQV Manager and collaborating with peers and contractors responsible for commissioning, qualification and validation of utility, process and lab systems in our GMP facility. This includes the design, generation, execution, and review of CQV testing for equipment and systems and their lifecycle management in compliance with FDA and EU regulations. You may represent the CQV department as an SME for CQV activities associated with utility, process and lab systems during regulatory inspections and audits. This role would be expected to complete CQV responsibilities for assigned systems in a timely manner working within our Quality system.

What will you do?

• Support execution of equipment validation protocols and associated reports (IQ, OQ, PQ) while adhering to the site Change Management process.
• Generate, review, approve and control departmental documentation (e.g., SOPs, protocols, final reports, data trends). Participate in document revisions, providing input, as vital.
• Build and complete Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities as per Thermo Fisher guidelines.
• Provide support for facility and equipment validation and revalidation programs.
• Perform temperature mapping for GMP warehouse, fridges, freezers, autoclaves, and other temperature controlled chambers.
• Generate deviations to protocols when vital based on CQV manager mentorship.
• Generate User Requirement Specifications (URS) and System Risk Assessments (SRA) using guidance from End User groups.
• Analyze and interpret validation test data to resolve whether systems or processes have met validation criteria or to identify root causes of deviations.
• Coordinate and execute validation aspects for key site projects to implement new equipment, technology, processes, or materials as required by the needs of the business aligned to the site objectives per direction of CQV management.

How will you get here?

Education:

• Bachelor's degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience:

• Minimum of 2-4 years' experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
• 2+ years within a GMP Environment preferred
• Hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries preferred.

Knowledge, Skills, Abilities (Required):

• 1+ years experience with performing temperature mappings of controlled environmental chambers (Refrigerators, Freezers, Incubators, and Cold Rooms) is required.
• Proficient in Computer applications and software (Microsoft Excel, Outlook, Word)
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Strong communication skills both written and verbal, including technical writing
• Ability to work on multiple projects simultaneously
• A high degree of proficiency towards use of computers is required.
• General knowledge of cGMP regulations and validation lifecycle requirements.

Knowledge, Skills, Abilities (Preferred):

• Experience in regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations).
• Global Systems e.g. Kneat, Trackwise, Documentum, etc.
• Extensive knowledge of validation activities including plan and protocol generation, execution, and final report approval/closeout.
• General knowledge of change control and performing validation impact assessments
• Experience with lab, process and utility equipment qualifications

Our global team of more than 100,000+ colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.