Manager, Validation

RXinsider LTD.; Greenville, Northern (NC, KY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

401K match

Tuition reimbursement

Job summary

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

Collaborating across functions, you’ll ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain validated states of systems enabling

Qualifications

• 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

Responsibilities

• Manage validation activities that ensure product quality and regulatory compliance
• Develop validation strategy and oversee validation of equipment, utilities, facilities, computer systems, and manufacturing processes
• Work across functions to ensure validation activities align with cGMP requirements
• Support new product introductions and technology transfers
• Maintain the validated state of systems that help produce therapeutics

Skills

cGMP knowledge

FDA/EU regulations

risk assessment

quality systems

technical writing

leadership

cross-functional collaboration

lean/continuous improvement

communication

proficient software

Education

Bachelor's degree in engineering/technical discipline

Advanced degree preferred

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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!