Process Engineer II - Downstream - Site Based, Redmond, WA

Evotec•Redmond, WA

18d•$80,000 - $90,000•Onsite

About The Position

The Process Engineer II Downstream for Site MSAT is part of a fast-paced, collaborative, and multidisciplinary team. The role reports to Downstream Lead for site MSAT, and is responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.

Requirements

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.