Senior Validation Engineer

Replimune•Framingham, MA

22d•$152,000 - $197,000•Onsite

About The Position

The Senior Validation Engineer 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 project manage validation campaigns to support maintaining validation 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 seven years professional experience in validation, engineering, or operations.
A minimum of seven years relevant experience in a cGMP environment is required.
Experience with GMP utilities and equipment is required.
Demonstrates professionalism, emotional intelligence, and the ability to build effective working relationships across functional teams.
Strong attention to details, flexibility and technical writing skills are important for this position.
Good knowledge of cGMP, GDP, and applicable regulatory requirements
Ability to work independently or in a team environment, while demonstrating initiative and accountability.

Nice To Haves

MSc or MS preferred.

Responsibilities

Serve as a validation technical leader, providing subject matter expertise in qualification and validation activities across facilities, utilities, equipment, processes, and computerized systems.
Act 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, vendor oversight and documentation review.
Establish, revise, and maintain validation project plans for qualification of equipment required for cGMP compliance.
Own and maintain validation procedures within area(s) of subject matter expertise.
Develop, review, approve, execute, and maintain validation lifecycle documents, including validation procedures, qualification/requalification protocols, and reports, in accordance with cGMP, GDP, and ALCOA principles.
Maintain qualified systems in a validated state through requalification, periodic review, continued verification, change control assessments, and evaluation of validation impacts resulting from proposed changes and deviations related to validated systems and processes.
Author and support investigation of deviations and CAPAs.
Assist with troubleshooting equipment / system failures.
Deliver training on validation program elements to Validation Engineers.
Maintain a strong understanding of the current regulatory landscape and proactively stays informed of evolving regulations, industry guidance, and compliance expectations applicable to validation activities.
Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), ALCOA principles, 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.
Accountable for managing assigned deliverables, maintaining project milestones, and ensuring proactive, accurate communication with cross-functional teams and stakeholders.