Job Title: MSAT Process Engineer

Our large CDMO client in Redmond is seeking a highly motivated Process Engineer for site MSAT to join a fast-paced, collaborative, and multidisciplinary team. The role report to the Sr Manager Manufacturing Compliance, and will be responsible to support manufacturing related deviations and process related change controls.

Roles and responsibilities:

• Authors and leads deviation investigations.
• Authors and reviews process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc).
• Authors and 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.
• Support continuous improvement initiatives for upstream or downstream process improvements.

Position Requirements:

• Masters (or Bachelors) degree in Engineering with 1+ (4+) years of pharmaceutical/biotech experience including a minimum of 2-4 years of supporting upstream cell culture or downstream purification manufacturing activities for biopharmaceutical products. (downstream experience preferred)
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Familiarity with root cause analysis methods and experience owning and authoring deviations.
• Good knowledge of Quality Management Systems and have experience working with various Manufacturing related document types.
• Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
• 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.