Senior Validation Engineer

Replimune Group; Framingham (MA); On-site; USD 152,000 - 197,000; Full time

Benefits offered by this job

Medical, dental & vision

401k match

Flexible time off

Year-end holidays

Job summary

Replimune Group, based in Framingham, MA, seeks a Senior Validation Engineer to qualify and maintain biotech facility equipment, utilities, instrumentation and computerized systems in a validated state.

You will coordinate with internal customers and contractors to plan, execute and review qualification protocols and reports, and manage validation campaigns through change control and requalification assessments.

Qualifications

• Seven+ years of professional experience in validation, engineering, or operations.
• Minimum seven years of relevant experience in a cGMP environment.
• Experience with GMP utilities and equipment.
• Strong attention to detail and technical writing skills.
• Ability to work independently or in a team with initiative and accountability.

Responsibilities

• Serve as a validation technical leader across facilities, utilities, equipment, processes, and computerized systems.
• Lead design, procurement and installation support for new equipment and facility expansions.
• Maintain validation project plans for qualification of equipment for cGMP compliance.
• Develop and maintain validation lifecycle documents and reports per cGMP, GDP, ALCOA.
• Assist with investigations of deviations and CAPAs and with audits/inspections.

Skills

Validation

cGMP experience

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor’s degree (Scientific/Engineering)

Job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

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.

Key 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

Other responsibilities

• 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.

Educational requirements:

• Bachelor’s degree in Scientific, Engineering or similar subject required, MSc or MS preferred.

Experience and skill requirement:

• 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.

Salary Range

Replimune 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 $152,000- $197,000. 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.

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.

For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.