Validation Engineer II

Replimune; Framingham (MA); On-site; USD 137,000 - 177,000; Full time

Benefits offered by this job

Performance bonus

Equity

401k match

Flexible time off

Paid holidays

Job summary

Replimune in Framingham, MA is seeking a Validation Engineer II to join the CQV team responsible for qualifying and maintaining facility equipment, utilities, instrumentation, and computerized systems in a validated state under applicable regulations.

You will collaborate with internal customers and external contractors to schedule, execute, and review qualification protocols and reports, manage CQV campaigns, and support change controls while ensuring GMP and GDP compliance.

Qualifications

• Five years of professional validation, engineering, or operations experience.
• Three years in a cGMP environment preferred.
• Experience with GMP utilities and equipment required.
• Excellent communication and interpersonal skills required.
• Attention to detail, flexibility, and technical writing skills are important.

Responsibilities

• Conduct impact and risk assessments and support user requirement specifications.
• Authors qualification, validation, and revalidation protocols and reports for facilities, equipment, and utilities.
• Ensure validation documentation complies with industry standards and regulatory requirements.
• Execute validation activities independently with limited supervision and manage risks.
• Coordinate scheduling, execution, and review of qualification/validation protocols and reports.
• Oversee vendors and contractors performing qualification activities.
• Collaborate with Engineering, Manufacturing, QA and other functions to support validation.
• Review and revise documentation to align with cGMP and GDP.
• Support change controls and deviations related to validated status.

Skills

Validation experience

Regulatory compliance

cGMP knowledge

Technical writing

Communication skills

Education

Bachelor's degree in scientific/engineering

MSc preferred

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 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 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 $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.

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.