New · posted Oct 13
Thermo Fisher Scientific · Pharmaceuticals
Validation Manager
- Allentown, PA
- On-site
- Full-time
- Manager
Closes Nov 12, 2026 · 30 days left
The role
Title: Validation Manager
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Discover Impactful Work
As a Validation Manager at Thermo Fisher Scientific, you will manage validation activities that ensure product quality and regulatory compliance. You'll develop validation strategy and oversee a team responsible for qualifying equipment, utilities, facilities, computer systems, and manufacturing processes.
What you need
Education/Experience
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 years of experience in validation in pharmaceutical/biotech manufacturing or related regulated industry required.
- Preferred Fields of Study: Engineering, Science, Chemistry, Biology, or related technical discipline.
- 3+ years of people management or team leadership experience.
- Experience with equipment, process, cleaning, computer system, and utility validation - temperature mapping experience preferred
- Experience with data integrity evaluation and knowledge of ALCOA++ principles
- Experience participating in regulatory inspections and customer audits
- Experience with validation master planning and change control systems
Knowledge, Skills, Abilities
- Expertise in risk assessment methodologies and statistical analysis
Demonstrated success managing complex validation projects and programs - Strong knowledge of cGMP regulations, particularly FDA and EU requirements
- Proficiency with quality systems and validation documentation
- Excellent technical writing and documentation skills
- Strong leadership, communication, and interpersonal abilities
- Ability to influence and collaborate across functions and levels
- Knowledge of lean/continuous improvement methodologies
- Proficient with standard business software applications
- Travel up to 10% as needed
What you'll do
- Working across functions, you'll ensure validation activities align with cGMP requirements while supporting new product introductions and technology transfers.
- This role offers the opportunity to make a meaningful impact by maintaining the validated state of systems that help produce therapeutics.
Pay
Thermo Fisher Scientific didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Where you'll work
Allentown, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Allentown, PASchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Fluctuating Temps hot/cold, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
Division/Site Specific Information
Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.
Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.
Job intelligence
The context around this role
Live data · October 13, 2026
Salary intelligence
How the pay compares
Manager roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $135,000 | $150,500 | $163,000 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 99 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification8
- Collaboration and leadership5
- GMP and compliance4
- Quality systems and risk4
- Data and digital systems4
- Lab testing and methods2
- Documentation and SOPs2
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
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Thermo Fisher on Regulatory Jobs
- 85
- Open roles
- 71
- Distinct roles
- 35
- Locations
By discipline
- Quality77 91%
- Regulatory6 7%
- Compliance & Safety2 2%
By level
- Senior & Principal35 41%
- Associate & Specialist28 33%
- Manager16 19%
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Validation Manager at Thermo Fisher
Applications close November 12.