Job Description

Job Title: CQV (Validation) Engineer III

Location: Carlsbad, CA

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 complex analytical challenges, improving patient diagnostics and therapies or increasing productivity 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 Scientific2019s 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 cutting-edge 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 III is part of a professional support staff reporting to the CQV Manager and collaborating with peers and contractors responsible for commissioning, qualification, and validation of GMP facilities, equipment and critical building and utility systems. This includes the design, implementation, and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations. Represents the department as an SME regarding validation issues during regulatory meetings and audits. Identifies and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management.

What will you do?

* Generate, review, approve and control departmental documentation (e.g., SOPs, protocols, final reports, data trends). Participate in document revisions, providing input, as necessary.
* Create and execute 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 expertise for the CQV revalidation program and for validation activities during the tech transfer of new products in the manufacturing facility.
* Analyze and interpret validation test data to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
* Co-ordinate 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.
* As part of the role you will represent the company at regulatory inspections (internal, external including FDA & MHRA), respond to questions, co-ordinate responses and corrective actions as appropriate.

How will you get here?

* Bachelor2019s Degree in Engineering, Science or related technical disciple
* Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.
* In depth knowledge of cGMP regulations.
* 5+ years within a GMP Environment
* 3 + years of experience within Validation
* Extensive knowledge of validation activities including plan and protocol generation, execution, and final report approval/closeout.
* Understanding and/or knowledge of change control and performing validation impact assessments.
* Experience with performing facility qualifications, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
* Experience with performing equipment qualification activities for the following systems: fermenters, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.
* Experience with performing utility qualification activities for the following systems preferred: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), CIP, Chilled Glycol, Wastes, etc.

Knowledge, Skills, Abilities

* Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
* 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.
* Leadership Skills: Proven ability to influence others and lead significant change.
* Strong communication skills both written and verbal, including technical writing
* Ability to work on multiple projects simultaneously