MSAT Process Engineer - Drug Substance

Actalent•Redmond, WA

40d•$55 - $70•Onsite

About The Position

We are 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.

Requirements

Masters (or Bachelors) degree in Engineering with 4+ (7+) 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 stakeholder
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

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.