Process Engineer

Seran BioScience

Bend, OR

JOB DETAILS
SKILLS
Analysis Skills, Auditing, Capacity Analysis, Commissioning, Continuous Improvement, Cost Control, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Dosage Forms, Drug Manufacturing, Facilities Engineering, Maintain Compliance, Manufacturing, Organizational Skills, Physical Demands, Process Engineering, Process Improvement, Project/Program Management, Regulations, Risk Analysis, Schedule Development, Standard Operating Procedures (SOP), Startup, Team Player, Technical Support
LOCATION
Bend, OR
POSTED
2 days ago

Seeking a Process Engineer to lead facility start-up, commissioning, and operational readiness for new commercial manufacturing. Responsible for designing, installing, and qualifying process systems (e.g., CIP, water, gases), optimizing processes for oral solid dosage forms, and ensuring cGMP compliance. Key duties include process design, capacity analysis, risk assessments, supporting tech transfers, and establishing maintenance schedules. Drive continuous improvement through data analysis, cost reduction, and efficiency projects. Contribute to project management, regulatory audits, and SOP development. Requires a BS/MS in engineering, 8+ years in pharmaceutical manufacturing, experience with facility start-up, and knowledge of cGMP standards. Preferred skills include experience with dosage forms, digital tools, and regulated environment design. Strong analytical, organizational, and cross-functional collaboration skills are essential. Physical requirements include work at desks and manufacturing sites, with some lifting. Compensation varies with experience. Benefits include paid time off, health plans, retirement contributions, and wellness support. Must be authorized to work in the U.S.; sponsorship not available.

About the Company

S

Seran BioScience