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
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
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
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
Frontier-Kemper Constructors, Inc.Framingham, Massachusetts, United States · On-site
$90k–$130k/yr
Pay Range: $90,000.00 - $ 130,000.00K Perini Management Services Inc., is seeking an in-person Estimator at our Home office in Framingham, MA. About Perini Management Services At home or abroad, our focus is on client sa…
Skills: Construction Estimating, Quantity Take-off, Subcontractor Management, Price Analysis, Microsoft Office Suite
Framingham, Massachusetts, United States · Hybrid
$75k–$100k/yr
At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives by improving access t…
Skills: Mental Health Therapy, Telehealth, Clinical Supervision, Case Consultation, Evidence-Based Treatment
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 · Hybrid
$50k–$60k/yr
Job Description: The Opportunity As a Business Development Representative, you play a vital role in maximizing the attainment of the company’s new business and revenue goals. You will be a hunter, at the forefront of the…
Skills: Cold Calling, Lead Qualification, Salesforce.com, Enterprise Selling, C-suite Penetration
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
We are growing! Fred Astaire Dance Studios® is excited to be adding to our team of professional dance instructors. We are currently hiring for Dance Instructor. Whether you have years of dance and/or dance instructor exp…
Skills: Dance Instruction, Customer Service, Interpersonal Skills, Ballroom Dance, Choreography
Framingham, Massachusetts, United States · On-site
$18/hr–$20/hr
Background 2Life Communities has been at the heart of positive change in the affordable senior housing ecosystem since 1965. We develop, manage, and advocate for high-quality, affordable housing and services that support…
Skills: Dishwashing, Sanitization, Kitchen Cleaning, Stock Rotation, Food Preparation
Framingham, Massachusetts, United States · On-site
$136k–$187k/yr
The B2B Campaign Operations Director is a strategic leadership role which supports Staples Business growth objectives by; a) overseeing our marketing email operations functions that support Staples Business; and b) matur…
Skills: B2B Marketing Operations, Customer Data Platform (CDP), Lead Management, Marketing Technology (Martech), Data Governance
Framingham, Massachusetts, United States · On-site
$90k–$120k/yr
Description Occupational Therapist (OTR) – Home Care | Full Time | Framingham, MA | Competitive Salaried Pay – Up to $120,000 Annually ***Now also offering Relocation/Sign On Bonuses - Inquire Today!*** Flexible Schedule…
Skills: Patient Evaluation, Treatment Planning, Activities Of Daily Living (ADLs), Home Safety Assessments, Adaptive Equipment Recommendation
Framingham, Massachusetts, United States · Remote OK
$22/hr–$28/hr
Staples is business to business. You’re what binds us together. While you may know Staples as the world’s leading office supply company, Staples Promotional Products – a division of Staples – is a national leader in the …
Skills: Customer Service, Relationship Management, Communication, Multitasking, Microsoft Excel
Framingham, Massachusetts, United States · On-site
Overview Retail Merchandiser SFS is growing, and we're looking for experienced Retail Merchandisers to join our nationwide network of independent contractors. This is an excellent opportunity for self-motivated professio…
Skills: Merchandising, Planogram Execution, Inventory Auditing, Product Resets, Display Maintenance
Framingham, Massachusetts, United States · On-site
$28/hr–$35/hr
Role: Responsible for assisting the Branch Manager in the direction and guidance of the daily operations of the branch. Trains, directs, and assists the Head Teller to achieve branch sales goals while maintaining an erro…
Skills: Branch Management, Staff Supervision, Employee Training, Performance Appraisal, Member Services
Michaels StoresFramingham, Massachusetts, United States · On-site
$15/hr–$17/hr
Store - Framingham, MA Build customer relationships while creating a memorable framing solution for their art. Help customers shop our store and be able to find what they’re looking for. Provide a safe, clean and clutter…
Skills: Custom Framing, Customer Service, Sales, Glass Cutting, Measuring Skills
Framingham, Massachusetts, United States · Hybrid
$75k–$100k/yr
At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives by improving access t…
Skills: Psychotherapy, Telehealth, Clinical Supervision, Case Consultation, Evidence-Based Treatment
Framingham, Massachusetts, United States · On-site
$160k–$208k/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: Statistical Analysis, Predictive Modelling, Data Visualization, ML/AI Integration, People Management
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
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The Senior Validation Engineer ensures that biotech facility equipment, utilities, and computerized systems are qualified and maintained in a validated state. This includes leading validation campaigns, authoring lifecycle documents, and managing change controls and deviations to ensure cGMP compliance.
Requires a Bachelor's degree in Science or Engineering (MSc preferred) and at least seven years of professional experience in validation within a cGMP environment. Candidates must possess strong technical writing skills and expertise in 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 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.
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.
Bachelor’s degree in Scientific, Engineering or similar subject required, MSc or MS preferred.
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.
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.
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
