Validation Engineer – Framingham, MA
Summary of job description:
The Validation Engineer is responsible for establishing and maintenance of validation plans and procedures for qualification of equipment at the Framingham, MA, manufacturing facility in accordance with appropriate regulatory guidance. The individual will work with customers and external contractors to coordinate scheduling, execution and review of qualification protocols / reports. The Validation Engineer will assist with setting up, qualifying & maintaining a monitoring system for GMP equipment. The individual will maintain the validated status of the facility and equipment through calibration, performance monitoring and requalification assessments.
- Establish, revise and maintain validation plans and procedures for qualification of equipment required for cGMP compliance
- Be responsible for qualification protocol and report generation, including acceptance criteria generation
- Coordinate scheduling, execution & review of qualification protocols / reports
- Manage vendors and contractors performing qualification activities
- Perform equipment requalification to ensure utilities and equipment remain compliant with required procedures and regulations
- Review, revise and complete documentation in accordance with cGMP
- Ensure equipment and building monitoring systems remain in validated compliance and support updates as new equipment added
- Provide impact assessments for change control and deviations related to validated status of utilities and equipment
- Assist with trouble shooting equipment / system failures
- Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of design, selection, commissioning and qualification of utilities and equipment
- 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
- BS in Scientific, Engineering or similar subject
Experience and skill requirement:
- A minimum of three years professional experience in validation, engineering, or operations.
- A minimum of one-year relevant experience in a cGMP environment is preferred.
- Experience with GMP utilities and equipment is preferred.
- 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.
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
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