Validation Manager

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 110,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific in Allentown, PA is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance across equipment, utilities, facilities, and computer systems.

You will develop validation strategy, mentor a team, and coordinate cross-functional efforts to support cGMP standards and tech transfers in a fast-paced pharmaceutical environment.

Qualifications

• Advanced Degree plus 4 years of validated experience in pharma/biotech manufacturing.
• Bachelor's Degree plus 6 years of validated experience in pharma/biotech manufacturing.
• 3+ years in people management or team leadership.
• Experience with equipment, process, cleaning, computer system, and utility validation.
• Temperature mapping experience preferred.
• Experience with data integrity evaluation and ALCOA++ principles.
• Experience participating in regulatory inspections and customer audits.
• Experience with validation master planning and change control systems.

Responsibilities

• Manage validation activities to ensure product quality and regulatory compliance.
• Develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems, and manufacturing processes.

Skills

Risk assessment methodologies

Statistical analysis

cGMP regulations

Quality systems documentation

Technical writing

Leadership

Cross-functional collaboration

Lean/continuous improvement

Proficient with standard software

Travel up to 10%

Education

Advanced Degree + 4 years experience

Bachelor's Degree + 6 years experience

Preferred fields: Engineering, Science, Chemistry, Biology

Job description

Work Schedule

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

Job Description

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.

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.

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.

A Day in the Life

• 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.

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 analysisDemonstrated 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

Benefits

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.