Validation Engineer III

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.)

Validation Engineer III

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.

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

Minimum Qualifications:

• 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

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

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!

Apply today!

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.