Work ScheduleFirst Shift (Days)
Environmental ConditionsAdherence 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.)
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!
