• MSAT Process Engineer - Drug Substance

    Actalent (Redmond, WA)


    Job Title: MSAT Process EngineerJob Description

     

    We are seeking a highly motivated Process Engineer for site MSAT to join a fast-paced, collaborative, and multidisciplinary team. The role reports to the Senior Manager of Manufacturing Compliance and will be responsible for supporting manufacturing-related deviations and process-related change controls.

    Responsibilities

    + Author and lead deviation investigations.

    + Author and review process-related documentation, including technical documents, test protocols, batch records, process descriptions, and SOPs.

    + Author and review change controls, including managing the implementation of changes as the assigned change agent.

    + Utilize technical skills and process knowledge to participate in or lead investigations related to process or new product implementation.

    + Collaborate with impacted groups to drive the implementation of CAPAs from approval to closure and effectiveness check.

    + Support continuous improvement initiatives for upstream or downstream process improvements.

    Essential Skills

    + Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology.

    + Familiarity with root cause analysis methods and experience owning and authoring deviations.

    + Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.

    + Good knowledge of Quality Management Systems and experience working with various manufacturing-related document types.

    + Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.

    + Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.

    Additional Skills & Qualifications

    + Master's (or Bachelor's) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience.

    + Minimum of 2-4 years of experience supporting upstream cell culture or downstream purification manufacturing activities for biopharmaceutical products (downstream experience preferred).

    + Good interpersonal, team, and collaborative skills are required.

     

    Work Environment

     

    The work environment is office-based, promoting a professional and collaborative setting.

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Redmond, WA.

    Pay and Benefits

    The pay range for this position is $55.00 - $70.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Redmond,WA.

     

    Application Deadline

     

    This position is anticipated to close on Dec 10, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.