Engineer II, Validation
About The Position
Thermo Fisher Scientific’s Clinical Diagnostic Reagents (CDR) group is seeking a Validation Engineer to support planning and execution of validation activities for clinical diagnostic reagent manufacturing within a cGMP, FDA, and ISO 13485 regulated environment. This role requires full onsite presence to support equipment, process, and system validation activities. This position will assist in development, execution, and documentation of validation protocols and reports while ensuring alignment with regulatory and site requirements. The role includes supporting periodic reviews and conducting gap assessments to ensure continued compliance with validation standards and site procedures. This position works under the guidance of senior validation engineers and reports directly to the Senior Manager of Engineering for the facility.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Chemistry or related technical field
- 2-3 years of validation experience in GMP/regulated industry (Medical Device or Pharmaceutical preferred)
- Familiarity with cGMP, FDA regulations, and industry standards (ISO, GAMP5)
- Strong technical writing skills for validation documentation
- Experience with IQ/OQ/PQ protocols and execution
- Proficiency in risk based quality tools (FMEA, Risk Analysis, RCA,CAPA)
- Experience managing validation projects independently
- Knowledge of calibration and metrology principles
- Experience with automation systems and computer system validation
- Ability to work in cleanroom environments when required
- Experience with quality management systems and documentation
- Knowledge of statistical analysis and process control methods
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
- Strong data analysis and problem-solving capabilities
- Clear verbal and written communication skills
- Proficient in Microsoft Office applications
- Effective interpersonal skills for team collaboration
- Ability to manage multiple projects
- Consistent record of completing projects on schedule in a deadline-oriented environment
Nice To Haves
- Relocation assistance is NOT provided.
Responsibilities
- Support creation and execution of validation master plans for facility equipment, systems, and processes
- Author, revise, and execute validation protocols (IQ, OQ, PQ) and associated reports
- Participate in periodic validation reviews and gap assessments to ensure ongoing compliance with regulatory and site standards
- Assist in identifying validation gaps and support development of remediation plans
- Analyze validation data to verify systems and processes meet defined acceptance criteria
- Collaborate cross-functionally with Engineering, Quality, Manufacturing, and other departments to coordinate validation activities
- Support deviation investigations, root cause analysis, and implementation of corrective actions
- Maintain validation documentation in accordance with site quality systems
- Support change control activities related to validated systems
- Assist in calibration coordination and verification activities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
