Downstream Process Engineer II – 24/7 MSAT

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

Benefits offered by this job

Discretionary annual bonus

Comprehensive benefits

401k company match

Flexible work

Paid time off

Job summary

Evotec (US) Inc. is seeking a Process Engineer II for Site MSAT downstream operations. The role supports multiple clinical-scale cGMP trains using Just-Evotec continuous processing in a 24/7 environment.

You will act as SME on project teams, drive process understanding, author and review critical documentation, and lead change controls and investigations with CAPA closure. Excellent English communication and collaboration are essential.

Qualifications

• Masters (or Bachelors) degree in Engineering with 2+ (5+) years of pharmaceutical/biotech experience including a minimum of 2-4 years of supporting downstream purification activities for biopharmaceutical products.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Technical purification and solution preparation operations using disposable-based manufacturing technologies.
• Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.

Responsibilities

• Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT, Operations and Quality functions.
• Develop process understanding and expertise.
• Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
• Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
• Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
• Monitors and reports on process performance data analysis.
• Ability to share 24/7 on call support activities during production.
• Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.

Skills

Process engineering

GMP experience

Team leadership

English communication

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Job description

Evotec (US) Inc. is seeking a Process Engineer II for Site MSAT downstream operations. The role supports multiple clinical-scale cGMP trains using Just-Evotec continuous processing in a 24/7 environment.

You will act as SME on project teams, drive process understanding, author and review critical documentation, and lead change controls and investigations with CAPA closure. Excellent English communication and collaboration are essential.