Validation Manager

Regulatory Toolkit; Greenville (NC); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Annual bonus

401K match

Tuition reimbursement

Benefits package

Zusammenfassung

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 qualification of equipment, utilities, facilities, computer systems, and manufacturing processes, aligning with cGMP and supporting tech transfers.

Experience in regulatory inspections and audits is valued, with 2+ years in team leadership.

Qualifikationen

• Bachelor's degree in engineering or related technical field.
• 6-8 years in pharmaceutical/biotech manufacturing.
• 2+ years validating equipment/process/utility.
• 3+ years people management or team leadership.
• 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.

Aufgaben

• Manage validation activities for product quality and regulatory compliance.
• Develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems and manufacturing processes.
• Ensure validation activities align with cGMP requirements and support tech transfers.
• Maintain the validated state of systems that help produce therapeutics.

Kenntnisse

cGMP knowledge

risk assessment

statistical analysis

documentation skills

leadership

cross-functional collaboration

Ausbildung

Bachelor's degree in engineering/science

Advanced degree preferred

Jobbeschreibung

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!

• competitive salary
• annual incentive bonus plan
• 401K with company match up to 6%
• tuition reimbursement
• 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!

• competitive salary
• annual incentive bonus plan
• 401K with company match up to 6%
• tuition reimbursement
• 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.