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As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Job Title: Cleaning Validation Engineer II

Requisition ID: 227992BR

When you’re part of the team at Thermo Fisher Scientific, 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

Patheon Softgels, a division of Thermo Fisher Scientific, has sites in High Point, North Carolina, USA and Tilbug, The Netherlands. Patheon Softgels primarily manufactures softgels for pharmaceutical (Rx), over the counter (OTC), and dietary supplements. The products are filed with the FDA, Health Canada, and EMA. The Cleaning Validation Engineer II position will be based at the High Point, North Carolina, USA site.

How will you make an impact?

The Cleaning Validation Engineer II will evaluate cleaning methods at the manufacturing site to ensure product safety. The Cleaning Validation Engineer will collaborate with Manufacturing, R&D, Quality Control, and Quality Assurance to develop validation documents.

What will you do?

• Prepare, execute and report validation protocols and assessments in line with cGMP’s, EU and other regulatory requirements and standards. Communicate cleaning validation findings clearly in written and verbal format.

• Prepares and reviews SOPs, Work Instructions (WIs) and Forms pertaining to cleaning validation.

• Provides technical support in resolving cleaning validation activities related to events/deviations.

• Train manufacturing associates to use validation concepts, tools, and documentation.

• Collaborate with departments within the organization to maintain and improve validation processes to ensure robust, efficient, and compliant processes.

How will you get here?

BS degree or equivalent in Life Sciences (Chemistry, Biology, Engineering, etc.) required and a minimum of 2 plus years' experience in the pharmaceutical and/or biotechnology/medical industry. Option of Associates Degree in science with 5 years of validation experience in the pharmaceutical industry.

• Experience in the pharmaceutical and/or biotechnology/medical industry with strong cGMPs (Current Good Manufacturing Practices).

• Experience with technical writing including risk assessments, protocols, and reports.

Knowledge, Skills, Abilities

• Excellent communication and listening skills (English language)

• Ability to build and maintain strong collaborative relationships across multiple departments

• Ability to organize and manage multiple tasks in a fast-paced environment.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one global 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.

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.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.