Planet Pharma

MES Validation Engineer

4625 Northeast Brookwood Parkway Hillsboro, OR 97124 US

Posted: 02/12/2026 2026-02-12 2026-03-15 Employment Type: Contract Job Category: Engineering Job Number: 625660 Pay Rate: 89.61 Is job remote?: No Country: United States

Job Description

The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently.

You will play a crucial role in supporting the multi-phase deployment of MES. As a Validation Engineer, you will own a dynamic range of responsibilities where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need.

Responsibilities

As a Validation Engineer, you will:

• Develop, draft and route for approval overall test scripts, validation protocols and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards.
• Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems
• Provide input on the validation strategy of the project
• Provide guidance on overall test strategy and ensure alignment with existing validated computer systems
• Execute formal validation in a GMP environment

Who you are

The ideal candidate brings:

• Experience in Rockwell FactoryTalk PharmaSuite
• 5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation
• Ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices
• A solid understanding of Computerized System Validation (CSV)
• Strong verbal and written communication skills
• Bachelors degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or a related life sciences discipline
• (Preferred) Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).
• Experience in managing testing plans and testing execution
• Experience with industry specific tools such as ERP systems, ValGenesis, LIMS, SCADA, and other regulated life sciences platforms

Pay Rate Range: $70-87/hr depending on experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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