New · posted Oct 15
Celldex Therapeutics · Biotechnology
Computer Validation Engineer IV
- Fall River, MA
- On-site
- Full-time
- Senior & Principal
Closes Aug 21, 2027 · 310 days left
The role
The incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle. This position works on moderately complex problems of diverse scope where analysis of data requires solid evaluation of identifiable factors.
What you need
- 8+ years applicable work experience in cGMP/GLP related industry
- Bachelor's degree in a technical discipline (computer or biological sciences), or equivalent
- Demonstrated experience coordinating validation projects in validated and regulated environments
- Demonstrated experience reviewing / evaluating legacy systems, and provide gap reports/assessments per each system per 21 CFR Par 11 compliance
- Experience with network qualification required
- Experience with ERP system qualification required
- Experience with Veeva products required
- Successful implementation of ERP, Veeva, lab, production systems required.
- Proven track record in validation and qualification of complex computer systems
- Demonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, 15 and GAMP standards
- Experience with qualification of AI preferred
- Experience with qualification of lab software systems required
- Excellent writing and communications skills
- Excellent people and interpersonal skills
- High level of collaboration and working on and leading teams
What you'll do
- Work closely with GMP, GLP and IT business units to provide Computer System Validation Services to implement validated system and maintain the validated state of current systems
- Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management for GMP/GLP systems.
- Applies and enhances existing computer system validation programs for the validation of new production and manufacturing /laboratory computer systems, including major capital projects and computer systems for both early phase and commercial phase.
- Ensure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex
- Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
- Develop Standard Operating Procedures and policies to support computer validation systems for GMP/GLP
- Develop training materials and provide training to Celldex staff related to the computer validation systems for GMP/GLP
- Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and IT
- Manages multiple simultaneous validation, revalidation, and change control activities
- Develop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP
- Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes for GMP/GLP systems
- Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state for GMP/GLP systems
Pay and benefits
$101,005 – $131,175 a year
Employer providedAnnual discretionary bonus
Long term incentive
401(k) with employer contribution
Health care and other insurance benefits
Paid holidays
Vacation and sick days
Where you'll work
Fall River, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Fall River, MAFrom the posting
About Celldex Therapeutics
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Equal opportunity, accessibility and legal noticesCelldex Therapeutics's statements, word for word
The expected base salary for this position is: $101005.00 to $131175.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% below 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 | $101,005 | — | $131,175 |
| Massachusetts (middle half) | $102,500 | $113,000 | $121,250 |
| All US (middle half) | $110,750 | $121,000 | $132,500 |
This role: Celldex Therapeutics'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 Celldex Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification17
- GMP and compliance12
- Data and digital systems12
- Documentation and SOPs7
- Quality systems and risk4
- Collaboration and leadership4
- Lab testing and methods1
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.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Celldex Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Quality5 100%
By level
- Director2 40%
- Associate & Specialist2 40%
- Senior & Principal1 20%
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Computer Validation Engineer IV at Celldex Therapeutics
Applications close August 21. $101K–$131K a year, employer provided.