Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
When you are part of the team at Thermo Fisher, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
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.
How will you make an impact?
As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.
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. This role requires full-time onsite presence at our Allentown, PA location.
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 the results of testing and determine the acceptability of results against pre-determined criteria.
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them
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
Coordinate with other departments or outside contractors/vendors to complete validation tasks
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
At Thermo Fisher Scientific, each one of our >100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer!
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.