Summary of job description: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.
Key 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.
Other responsibilities- 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.
Educational requirements:- Bachelor's degree in Scientific, Engineering or similar subject required, MSc preferred.
Experience and skill requirement:- A minimum of five years professional experience in validation, engineering, or operations.
- A minimum of three years relevant experience in a cGMP environment is preferred.
- 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.
Salary RangeReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $137,000-$177,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
