Downstream Process Engineer II - Flexible Hours, 24/7 Ops

Evotec; Redmond (WA); On-site; USD 86,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k match

Flexible work

Paid time off

Job summary

Just Evotec Biologic is seeking a passionate Process Engineer II (Downstream) to join the MSAT site in Redmond. You will support downstream purification activities for clinical-scale cGMP manufacturing trains on a 24/7 basis, driving process understanding and continuous improvements.

You'll collaborate with global MSAT, Operations and Quality teams, author technical documents, lead investigations, and contribute to CAPA closure while applying Quality by Design principles in a fast-paced biotech

Qualifications

• Masters or bachelor’s degree in Engineering with 2+ (5+) years of pharma/biotech experience.
• Experience supporting downstream purification activities for biopharmaceutical products.
• Proven GMP pharmaceutical/biotech leadership in a regulated environment.
• Ability to work with high-performing teams and influence internal/external stakeholders.
• Excellent verbal and written English communication.
• Experience leading risk assessment and applying principles of Quality by Design.

Responsibilities

• Represent site MSAT on project teams as SME; interface with global MSAT, Operations and Quality.
• Develop process understanding and expertise in downstream processing.
• Authors, reviews and owns process documentation (tech docs, test protocols, batch records, SOPs).
• Authors, reviews change controls and manages change implementation.
• Lead investigations related to process or new product implementation; drive CAPA from approval to closure.
• Monitor and report on process performance data analysis.
• Provide 24/7 on-call support during production as needed.
• Lead continuous improvement for downstream processes using Operational Excellence.

Skills

GMP experience

Biotech/pharma experience

Team leadership

Communication skills

Risk assessment

Quality by Design

Education

Engineering degree (MS or BS)

Job description

Just Evotec Biologic is seeking a passionate Process Engineer II (Downstream) to join the MSAT site in Redmond. You will support downstream purification activities for clinical-scale cGMP manufacturing trains on a 24/7 basis, driving process understanding and continuous improvements.

You'll collaborate with global MSAT, Operations and Quality teams, author technical documents, lead investigations, and contribute to CAPA closure while applying Quality by Design principles in a fast-paced biotech