Validation Associate, Facilities and Operations

Serán BioScience • Bend, OR

5d • Onsite

About The Position

The Validation Associate supports validation activities for pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. The role helps maintain, schedule, and execute qualification and validation activities for manufacturing tablets, capsules, and spray-drying dispersion for clinical FDA trials. The successful candidate supports the validation life cycle, including design, operation, continuous improvement, and decommissioning. Pharmaceutical industry experience in a GMP environment is preferred.

Requirements

• Broad knowledge of pharmaceutical GMP and FDA and international regulations.
• General understanding of change control, CAPA programs, investigations, root cause analysis, and good documentation practices.
• Excellent verbal and written communication skills.
• Excellent interpersonal and collaborative teamwork skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills and a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Proven project management skills while working independently.
• Ability to prioritize tasks and delegate when appropriate.
• Ability to function well in a fast-paced and sometimes stressful environment.
• Proficiency with Microsoft Office Suite or related software.
• Bachelor’s degree, preferably in a scientific discipline; equivalent experience may be considered in lieu of a degree.
• 0–2 years of previous GMP experience with a background in the pharmaceutical, biotech, chemical, validation, or QA industry.

Nice To Haves

• Pharmaceutical industry experience within a GMP environment.

Responsibilities

• Develop and manage system lifecycle documentation, including User Requirements (URS), Functional and Design Specifications, testing protocols (Cx/IQ/OQ/PQ), traceability matrices, qualification summary reports, change controls, and risk assessments.
• Assist with generating and maintaining SOPs and supporting documents.
• Work with cross-functional teams to troubleshoot equipment, process, and validation issues.
• Perform responsibilities in compliance with applicable GMP regulations and guidelines for systems qualification, cleaning, and process validation.
• Ensure equipment is released for GMP use within agreed-upon timelines after qualification and cleaning activities.
• Perform investigations, CAPAs, change requests, and engineering projects.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level