New · posted Oct 15
Replimune · Biotechnology
Validation Engineer II
- Framingham, MA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
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.
Skills named in this posting
What you'll do
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.
Pay and benefits
$137,000 – $177,000 a year
Employer providedReplimune 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.
Annual performance incentive bonus
New hire and performance-based equity
Medical, dental, and vision insurance
401k match
Flexible time off
Paid holidays including year-end shutdown
Where you'll work
Framingham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Framingham, MAFrom the posting
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.
Equal opportunity, accessibility and legal noticesReplimune's statements, word for word
We are an Equal Opportunity Employer.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 30% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts10 roles publishing pay
Senior & Principal roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $137,000 | — | $177,000 |
| Massachusetts (middle half) | $102,500 | $113,000 | $121,250 |
| All US (middle half) | $110,750 | $121,000 | $132,500 |
This role: Replimune's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 111 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Replimune's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification9
- GMP and compliance8
- Documentation and SOPs7
- Collaboration and leadership7
- Quality systems and risk4
- Investigations and CAPA3
- Lab testing and methods2
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Replimune on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 2
- Locations
By discipline
- Quality6 86%
- Regulatory1 14%
By level
- Senior & Principal5 71%
- Manager1 14%
- Associate & Specialist1 14%
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Validation Engineer II at Replimune
Open until filled. $137K–$177K a year, employer provided.