Biologics Process Engineer III: Tech Implementation & CQV

Evote; Union Hill-Novelty Hill (WA); On-site; USD 92,000 - 127,000; Full time

Benefits offered by this job

Comprehensive benefits

401k match

Flexible work

Paid time off

Wellness benefits

Transportation benefits

Job summary

Just-Evotec Biologics is seeking a Process Engineer III to join the Global MSAT Process Engineering team in Redmond, WA. You will bring new equipment and technologies into our biologics manufacturing network, working with Manufacturing, MSAT, Automation, and vendors to evaluate, design, test, procure, and implement solutions.

You will develop documentation for qualification and validation, support regulatory submissions, audits, and site inspections, and help shape how new technologies are

Qualifications

• BS in engineering, sciences, or related life science engineering; 5+ years in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years.
• Strong knowledge of single-use processing equipment used in biopharmaceutical manufacturing.
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Working knowledge of cGMP manufacturing and regulatory requirements for biologics/pharmaceuticals.
• Solid understanding of monoclonal antibody processing at manufacturing scale or process development.
• Experience with single-use disposable manufacturing systems.
• Demonstrated ability to work independently and on cross-functional teams.
• Working knowledge of manufacturing process equipment and automation systems.
• Focus on quality, attention to detail, and effective task/time management.
• Ability to organize, analyze/interpret, and communicate process data.
• Excellent oral and written communication skills.

Responsibilities

• Partner with stakeholders and vendors to evaluate and implement new manufacturing technologies.
• Develop URS and FS to support qualification and validation requirements.
• Collaborate on DCS design and integration with manufacturing equipment.
• Support evaluations of facility and utility requirements for equipment.
• Lead evaluation of single-use technologies and manifolds.
• Work with vendors to develop testing data and validation packages.
• Support procurement, implementation, qualification, and lifecycle management of technologies.
• Develop SOPs, training materials, and maintenance plans.
• Lead investigations of non-conformance and deviations and assess process impact.
• Share knowledge across the manufacturing network.
• Participate in audits and regulatory inspections as needed.

Skills

Single-use equipment

Cross-functional teamwork

Regulatory compliance

Process data analysis

Excellent communication

Education

BS in engineering or life sciences

Tools

DeltaV automation

DCS integration

URS/FS documentation

Job description

Just-Evotec Biologics is seeking a Process Engineer III to join the Global MSAT Process Engineering team in Redmond, WA. You will bring new equipment and technologies into our biologics manufacturing network, working with Manufacturing, MSAT, Automation, and vendors to evaluate, design, test, procure, and implement solutions.

You will develop documentation for qualification and validation, support regulatory submissions, audits, and site inspections, and help shape how new technologies are