Position Title: Validation Engineer
Work Location: Hillsboro, OR 97124
Assignment Duration: 4+ months
Work Arrangement: Onsite

Position Summary:
The Hillsboro Innovative Therapies team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing.
As a member of the Manufacturing Execution System team, you will bring state of the art automation technology to the site.

Background & Context:
The Organization works with individualized DNA/RNA therapies, cell therapies, and stem cell therapies.

Key Responsibilities:

• 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.

Qualification & Experience:

• 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.

• Bachelor’s 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 89.28/hr.