MSAT Process Engineer - Drug Substance

Job Title: Process EngineerJob Description

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We are seeking two experienced Process Engineers to join our Manufacturing Science and Technology (MSAT) team, supporting drug substance operations. This role is critical in helping manage deviation backlogs, support change controls, and prepare for upcoming Process Performance Qualification (PPQ) runs. The ideal candidate will bring strong technical writing skills, deviation ownership experience, and a solid background in drug substance manufacturing.

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Responsibilities

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  Author and own deviations, including root cause analysis and CAPA development.

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  Support technical assessments for new product introductions and site operations.

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  Contribute to batch record revisions and change control processes.

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  Assist in preparing documentation and readiness for PPQ campaigns.

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  Collaborate cross-functionally with QA, Manufacturing, and Engineering teams.

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  Utilize Compliance Quest and other quality systems to manage documentation.

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  Prioritize assigned deviations and manage workload independently.

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  Support SOP updates and other GMP documentation as needed.

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Essential Skills

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  Bachelor’s degree in Engineering (Chemical, Biochemical, or related field) required.

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  4–8 years of experience in a drug substance manufacturing or MSAT role.

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  Proven experience authoring deviations and performing root cause investigations.

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  Strong technical writing skills with attention to detail and compliance.

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  Familiarity with batch records, change controls, and CAPA processes.

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Additional Skills & Qualifications

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  Understanding of PPQ and regulatory expectations (preferred).

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  Experience working in or with CMOs such as AGC Biologics, Pfizer, or BMS is a plus.

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  Self-starter with excellent communication and collaboration skills.

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Work Environment

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This position is based in an office environment.

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Pay and Benefits

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The pay range for this position is $50.00 - $65.00/hr.

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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:

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• 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)

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Workplace Type

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This is a fully onsite position in Redmond,WA.

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Application Deadline

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This position is anticipated to close on Aug 27, 2025.

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About Actalent

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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.

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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.

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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 (% ) for other accommodation options.