Validation Engineer III

Thermo Fisher Scientific•Allentown, PA

48d•Onsite

About The Position

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. 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. 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.

Requirements

A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science field and 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 Computer System Validation (CSV)
Knowledge of Controlled Temperature Unit Operation and Management
PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word
Should possess effective 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
Must be able to lift 35 pounds

Nice To Haves

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

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 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