Validation Manager

ThermoFisher Scientific; Greenville (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual incentive bonus

401K with company match up to 6%

Tuition reimbursement

Career development opportunities

Job summary

Thermo Fisher Scientific is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance. You will develop validation strategy and oversee a team qualifying equipment, utilities, facilities, computer systems and manufacturing processes.

In this role you will ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain the validated state of systems that produce therapeutics.

Qualifications

• Bachelor’s degree in engineering, science, chemistry, biology or related technical discipline; advanced degree preferred.
• 6–8 years of pharma/biotech manufacturing experience.
• 2+ years leading validation or related activities.
• 3+ years of people management or team leadership experience.
• Experience with validation master planning and change control systems.
• Experience with regulatory inspections and audits.

Responsibilities

• Manage validation activities to ensure product quality and regulatory compliance.
• Develop validation strategy and oversee a team responsible for qualifying equipment, utilities, facilities, computer systems and processes.
• Ensure validation activities align with cGMP requirements across functions.
• Support new product introductions and technology transfers.
• Maintain the validated state of systems used to produce therapeutics.

Skills

Leadership

cGMP knowledge

Risk assessment

Statistical analysis

Documentation

Cross-functional collaboration

Communication

Lean/Continuous improvement

Education

Bachelor's degree in engineering/science/chemistry/biology or related technical discipline

Advanced Degree preferred

Tools

Quality systems

Change control systems

Statistical software

Job description

Work Schedule

First Shift (Days)

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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

DESCRIPTION:

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. 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:

• Bachelor's degree in engineering, science, chemistry, biology or related technical discipline. Advanced Degree preferred
• 6 - 8 years of experience in pharmaceutical/biotech manufacturing industry
• 2+ years of experience with equipment, process, cleaning, and/or utility validation is required.
• 3+ years of people management or team leadership experience
• Demonstrated success managing complex validation projects and programs
• Experience with validation master planning and change control systems
• Experience participating in regulatory inspections and customer audits
• Experience with smoke studies would be a plus

KNOWLEDGE, SKILLS, ABILITIES:

• Strong knowledge of cGMP regulations, particularly FDA and EU requirements
• Expertise in risk assessment methodologies and statistical analysis
• 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

NOTE: We are not able to offer relocation assistance or visa sponsorship for this role at this time.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team. We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

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.