Validation Engineer II

Key Responsibilities

• Cover 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.

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.
• Aid in internal and regulatory agency audits / inspections.
• Ensure training is kept in GMP compliant state.

Qualifications

• Bachelor’s degree in Scientific, Engineering or similar subject required, MSc preferred.
• Minimum of five years professional experience in validation, engineering, or operations.
• 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 of cGMP & GDP requirements.
• Ability to work independently or in a team environment as well as being self-motivated and showing initiative.

Pay

Salary Range: $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.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options.

We are an Equal Opportunity Employer.