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Validation Engineer III

Employer
Thermo Fisher Scientific
Location
Allentown, PA
Closing date
Jun 24, 2022

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As part of the Thermo Fisher Scientific team, youll 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 worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time a concept that we internally embrace as There is a Patient Waiting. Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,500 employees in over 15 countries work hard every day knowing that what they do matters.

What will you do?

As a Validation Engineer III, 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.

Responsibilities:
  • Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of corresponding summary reports
  • 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 Is: 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

Minimum Qualifications:
  • A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science field is required.
  • 2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP 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

Desired Qualifications:
  • Proficient with Mini-Tab or similar statistical analysis software
  • Knowledge of pharmaceutical packaging materials and equipment

Physical Requirements
  • Must be able to lift 35 pounds

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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one 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! http://jobs.thermofisher.com

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

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