Job Title: Staff Validation Engineer

Requisition ID: 226604BR

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 live 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.

How will you make an impact?

As a Staff Validation Engineer you will be responsible to interact with several departments to provide validation support for computer systems, equipment and processes, along with the critical utilities and facilities required for packaging operations at the site. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state.

What will you do?

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• Position will support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ.
• Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment
• Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.
• Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)
• Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems
• Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies
• Work closely with engineering to coordinate and complete Factory Acceptance Testing (FAT) activities and protocols
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
• Provide constant communications with all affected departments and personnel regarding validation activities
• Assist with identification and execution of Validation Master Plan (VMP) as required
• Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement
• Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
• Conducts all activities in a safe and efficient manner
• Other duties may be assigned to meet business needs
  

How will you get here?
Education

• Bachelor of Science degree from an accredited college or university in an Engineering or Science field
• 5+ years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience
  

Experience:

• Knowledge of Controlled Temperature Unit Operation and Management
• PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word
• Must have strong social skills
• Must have strong analytical skills
• Must be able to multitask and respond to shifting priorities
• Must have good communication skills, both written and verbal
• Must be results oriented
• Must have prior mechanical and process equipment experience

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

The salary range estimated for this position is $106,500 - $162,750. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount