Framingham, Massachusetts, United States · On-site
$137k–$177k/yr
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 o…
Skills: Validation, CQV, cGMP, GDP, Technical Writing
Woburn, Massachusetts, United States · Remote OK
$217k–$281k/yr
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 o…
Skills: KOL Relationship Management, Clinical Development, Competitive Intelligence, Oncology Expertise, Project Leadership
Woburn, Massachusetts, United States · Remote OK
$209k–$270k/yr
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 o…
Skills: KOL Relationship Management, Oncology Expertise, Clinical Development, Competitive Intelligence, Project Leadership
Woburn, Massachusetts, United States · Hybrid
$307k–$397k/yr
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 o…
Skills: Pharmacovigilance, Signal Detection, Risk Management, Benefit Risk Assessment, Oncology
Framingham, Massachusetts, United States · On-site
$152k–$197k/yr
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 o…
Skills: Validation Engineering, cGMP Compliance, GDP, ALCOA Principles, Equipment Qualification
Woburn, Massachusetts, United States · Hybrid
$221k–$286k/yr
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 o…
Skills: Revenue Operations, Order-to-Cash, Gross to Net Accounting, Oracle, SOX Compliance
Framingham, Massachusetts, United States · On-site
$120k–$155k/yr
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 o…
Skills: Quality Assurance, cGMP Compliance, Good Documentation Practices, Batch Record Review, Deviations Management
Abingdon, England, United Kingdom · On-site
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 o…
Skills: Batch Review, GMP Compliance, Quality Assurance, CAPA, Root Cause Analysis
Framingham, Massachusetts, United States · On-site
$66k–$86k/yr
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 o…
Skills: cGMP, SOP Adherence, Equipment Operation, Batch Record Documentation, Visual Inspection
Framingham, Massachusetts, United States · On-site
$95k–$123k/yr
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 o…
Skills: cGMP Manufacturing, Aseptic Gowning, SOP Authoring, Single-Use Technology, Tangential Flow Filtration
Framingham, Massachusetts, United States · On-site
$189k–$244k/yr
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 o…
Skills: Aseptic Operations, cGMP Compliance, Sterile Product Development, Contamination Control Strategy, Risk Management
Woburn, Massachusetts, United States · On-site
$87k–$113k/yr
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 o…
Skills: cGMP Manufacturing, Aseptic Gowning, SOP Authoring, Batch Records, Single-Use Technology
Framingham, Massachusetts, United States · On-site
$66k–$86k/yr
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 o…
Skills: cGMP, SOP Adherence, Equipment Operation, Batch Documentation, Visual Inspection
Woburn, Massachusetts, United States · Hybrid
$214k–$277k/yr
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 o…
Skills: HCP Marketing, Product Launch, Tactical Marketing Planning, KOL Engagement, Campaign Development
Framingham, Massachusetts, United States · On-site
$148k–$192k/yr
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 o…
Skills: Equipment Engineering, Utilities Engineering, cGMP, Technical Writing, Root Cause Analysis
Framingham, Massachusetts, United States · On-site
$102k–$132k/yr
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 o…
Skills: Document Control, Quality Systems Management, cGMP Compliance, Good Documentation Practices, MasterControl
Framingham, Massachusetts, United States · On-site
$100k–$129k/yr
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 o…
Skills: cGMP, GDP, Quality Assurance, Batch Record Review, CAPA
Woburn, Massachusetts, United States · Hybrid
$81k–$104k/yr
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 o…
Skills: US GAAP, General Ledger Accounting, Account Reconciliation, Journal Entries, Oracle Fusion
Framingham, Massachusetts, United States · On-site
$113k–$146k/yr
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 o…
Skills: QC Analytical Testing, cGMP, SOP Development, Method Qualification, OOS Investigations
Abingdon, England, United Kingdom · On-site
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 o…
Skills: GMP Compliance, Quality Management System, Batch Review, Change Control, Deviation Management
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The Validation Engineer II ensures that biotech facility equipment, utilities, and computerized systems are qualified and maintained in a validated state. This includes authoring protocols, managing CQV campaigns, and collaborating with cross-functional teams to support regulatory compliance.
Requires a Bachelor's degree in Science or Engineering with at least five years of professional experience in validation or operations. Candidates should have a strong knowledge of cGMP/GDP requirements and experience with GMP utilities and equipment.
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:
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.
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.
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.
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.
Bachelor’s degree in Scientific, Engineering or similar subject required, MSc preferred.
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.
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.
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.
Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel oncolytic immunotherapies. We imagine a world where cancer is a curable disease.
Offices: Woburn, MA 01801, US
Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel oncolytic immunotherapies. We imagine a world where cancer is a curable disease.
Offices: Woburn, MA 01801, US
