Validation Engineer II

When you’re 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?

Validation is the process of establishing documented evidence that a procedure, process, equipment or other activity will consistently perform as intended throughout its life cycle. As a Validation Engineer II, you will be responsible to interact with several departments to create and execute validation testing in support of individual equipment, systems, environments, cleaning efficiency, or processes required for pharmaceutical packaging operations at the site.

Responsibilities:

• Within a Pharmaceutical organization, individual will be responsible for the preparation and execution of validation protocols (VP, IQ, OQ, PQ, and others), along with their associated summary reports, in service of items including:

  • Packaging equipment (Bottle fillers, capsule fillers, syringe assembly)

  • Storage environments (Freezers, Refrigerators and Cold rooms)

  • Environments (Air Handling and HEPA filtration)

  • Utilities (i.e. water, clean air)

  • Computer control systems, including a Building Automation System (BAS)

  • Cleaning efficacy

  • Other specialized areas as project are requested

• Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices).

• Prepare detailed reports or design statements knowledge obtained from learning about new equipment coming to the site.

• Coordinate Validation Projects with other departments and ensure project timelines

• Manage and maintain validation test equipment, as assigned

• Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and Involvement

• Author SOPs related to validation department activities

• Conducts all activities in a safe and efficient manner

• Other duties may be assigned to meet business needs

Minimum Qualifications:

• Associates degree required. Bachelor of Science degree, preferred.

• 1-2 years of validation experience in a regulated industry or equivalent validation experience including food or pharmaceutical packaging

• PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word

• Must independently drive projects through clear communications, schedules, and team meetings

• Must have strong interpersonal 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 mechanical and process equipment aptitude

• Knowledge of pharmaceutical packaging materials and packaging equipment is desirable

Physical Requirements

• Must be able to lift 35 pounds

At Thermo Fisher Scientific, each one of our 70,000 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 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.