Sr Manager, Validation

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, 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.

Excellent Benefits Package

Review our company's Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

ThermoFisher's Middletown Facility, employs over 450 professionals supporting manufacturing of IVD products focused on Immunological Assays, Biologicals and Clinical Chemistries (reagents, calibrators, diluents, bulks, controls) used in clinical diagnostics by clinical laboratories and hospitals to conduct various biochemical and hematological assays on human samples.

A day in the Life:

Make an impact! The Sr. Manager, Validation Engineering is a key part of the operations team in a Clincal Diagnostics manufacturing site, leading and guiding our overall medical device and IVDR process and test method validation strategy. Successful candidate will lead and develop a team of 4-5 dedicated Validation Engineers as well as engaging with and mentoring various other process engineers as needed. Daily tasks will include:

• Developing and refining our validation strategy and overall approach
• Ensuring the initiation, preparation, and closeout of all validation-related documents and change controls.
• Evaluate proposed changes to validated systems and recommend level of validation required
• Coordinated project management activities for validation projects are within scope and budget
• Uses a risk-based approach to develop and maintain compliant and cost-effective processes
• Develops and supports procedures including Statistical Process Control and Continued Process Verification to maintain validated state
• Key subject representative for regulatory and agency audits with respect to Validation

Keys to Success:
Education

• Bachelor's Degree in Biology, Chemistry, Engineering, Mathematics or related Technical Physical Science required

Experience

• 5+ years proven ability in Validation Required
• 3+ years proven experience in a GXP Medical, Pharma or IVD facility required
• Lean Sigma (or equivalent certification) Green Belt Required. Black Belt highly preferred.
• Experience with prior team leadership preferred

Knowledge, Skills, Abilities

• Proficiency with process, cleaning and test method validation methodologies in a regulated manufacturing environment.
• Able to successfully coordinate workload and timelines
• Strong project management, problem-solving, and analytical skills

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