Validation Engineer II
About The Position
The Validation Engineer II will work as part of a larger validation team to ensure the biotech facility equipment, utilities, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance. The individual will work with internal customers and external contractors to coordinate scheduling, execution, and review of qualification protocols / reports. The individual will manage CQV campaigns to support maintaining CQV through change control, assessments, performance monitoring and requalification assessments. This position is based in our Framingham location and typically has a 5-day on-site expectation.
Requirements
- A minimum of five years professional experience in validation, engineering, or operations.
- Experience with GMP utilities and equipment is required.
- Excellent communication and interpersonal skills are required.
- Attention to detail, flexibility and technical writing skills are important for this position.
- Good knowledge cGMP & GDP requirements
- Ability to work independently or in a team environment as well as being self-motivated and showing initiative.
Nice To Haves
- A minimum of three years relevant experience in a cGMP environment is preferred.
- MSc preferred.
Responsibilities
- Conduct impact and risk assessments and support the development of user requirement specifications, as needed.
- Authors qualification, validation, and revalidation protocols and reports for facility, equipment, and critical utilities.
- Ensure validation documentation complies with industry standards, approved procedures, and current regulatory requirements.
- Independently execute validation activities with limited supervision while identifying, communicating, and escalating project risks and compliance concerns as appropriate.
- Coordinate scheduling, execution, and review of qualification and validation protocols and reports.
- Coordinate and oversee vendors and contractors performing qualification activities.
- Collaborate with Engineering, Manufacturing, Quality Assurance, and other functional areas to support validation and qualification activities.
- Review, revise, and complete documentation in accordance with cGMP and GDP.
- Support change controls and deviations by performing impact assessments related to the validated status of utilities, equipment, instruments, and systems.
- Assist with trouble shooting equipment and system failures and support investigations, as required.
- Responsible for other duties and projects as assigned.
- Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
- Support equipment and process related non-conformance investigations and change control activities.
- Assist with internal and regulatory agency audits / inspections.
- Ensure training is kept in GMP compliant state.
Benefits
- medical, dental, and vision insurance
- 401k match
- flexible time off
- a number of paid holidays including year-end shutdown
- annual performance incentive bonus
- new hire equity
- ongoing performance-based equity
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
