Sr Manager, Validation

at  Thermo Fisher Scientific

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

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

• 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 Validatio