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MSAT Process Engineer - Drug Substance
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Actalent 2 days ago Be among the first 25 applicants Join to apply for the
MSAT Process Engineer - Drug Substance
role at
Actalent Get AI-powered advice on this job and more exclusive features. Job Description
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. Job Title: Process Engineer
Job Description
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.
Responsibilities
Author and own deviations, including root cause analysis and CAPA development. Support technical assessments for new product introductions and site operations. Contribute to batch record revisions and change control processes. Assist in preparing documentation and readiness for PPQ campaigns. Collaborate cross-functionally with QA, Manufacturing, and Engineering teams. Utilize Compliance Quest and other quality systems to manage documentation. Prioritize assigned deviations and manage workload independently. Support SOP updates and other GMP documentation as needed.
Essential Skills
Bachelor’s degree in Engineering (Chemical, Biochemical, or related field) required. 4–8 years of experience in a drug substance manufacturing or MSAT role. Proven experience authoring deviations and performing root cause investigations. Strong technical writing skills with attention to detail and compliance. Familiarity with batch records, change controls, and CAPA processes.
Additional Skills & Qualifications
Understanding of PPQ and regulatory expectations (preferred). Experience working in or with CMOs such as AGC Biologics, Pfizer, or BMS is a plus. Self-starter with excellent communication and collaboration skills.
Work Environment
This position is based in an office environment.
Pay and Benefits
The pay range for this position is $50.00 - $65.00/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 Aug 27, 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 actalentaccommodation@actalentservices.com for other accommodation options. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Management and Manufacturing Industries Business Consulting and Services Referrals increase your chances of interviewing at Actalent by 2x Get notified about new Process Engineer jobs in
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MSAT Process Engineer - Drug Substance
role at
Actalent 2 days ago Be among the first 25 applicants Join to apply for the
MSAT Process Engineer - Drug Substance
role at
Actalent Get AI-powered advice on this job and more exclusive features. Job Description
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. Job Title: Process Engineer
Job Description
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.
Responsibilities
Author and own deviations, including root cause analysis and CAPA development. Support technical assessments for new product introductions and site operations. Contribute to batch record revisions and change control processes. Assist in preparing documentation and readiness for PPQ campaigns. Collaborate cross-functionally with QA, Manufacturing, and Engineering teams. Utilize Compliance Quest and other quality systems to manage documentation. Prioritize assigned deviations and manage workload independently. Support SOP updates and other GMP documentation as needed.
Essential Skills
Bachelor’s degree in Engineering (Chemical, Biochemical, or related field) required. 4–8 years of experience in a drug substance manufacturing or MSAT role. Proven experience authoring deviations and performing root cause investigations. Strong technical writing skills with attention to detail and compliance. Familiarity with batch records, change controls, and CAPA processes.
Additional Skills & Qualifications
Understanding of PPQ and regulatory expectations (preferred). Experience working in or with CMOs such as AGC Biologics, Pfizer, or BMS is a plus. Self-starter with excellent communication and collaboration skills.
Work Environment
This position is based in an office environment.
Pay and Benefits
The pay range for this position is $50.00 - $65.00/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 Aug 27, 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 actalentaccommodation@actalentservices.com for other accommodation options. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Management and Manufacturing Industries Business Consulting and Services Referrals increase your chances of interviewing at Actalent by 2x Get notified about new Process Engineer jobs in
Kirkland, WA . Seattle, WA $77,968.80-$110,000.00 4 days ago Redmond, WA $139,000.00-$200,000.00 2 weeks ago Senior Operations Engineer, AMZL Process Engineering
Bellevue, WA $107,600.00-$177,900.00 1 week ago Redmond, WA $112,000.00-$148,000.00 2 days ago Bothell, WA $70,000.00-$85,000.00 1 week ago Redmond, WA $111,000.00-$164,000.00 2 weeks ago Redmond, WA $139,000.00-$200,000.00 3 days ago Manufacturing and Process Engineer, PCBA (Starlink)
Kirkland, WA $95,000.00-$105,000.00 1 month ago Everett, WA $125,257.00-$208,762.00 1 month ago Senior Process Innovation Engineer, Amazon Logistics
Bellevue, WA $107,600.00-$177,900.00 2 weeks ago Redmond, WA $111,000.00-$164,000.00 2 weeks ago Sr. Process Safety Engineer, Global Process Safety Engineering & Management, Workplace Health & Safety
Bellevue, WA $128,600.00-$213,600.00 1 week ago Sr. Process Safety Engineer, Global Process Safety Management, Workplace Health & Safety
Bellevue, WA $128,600.00-$213,600.00 1 week ago Redmond, WA $112,000.00-$148,000.00 4 days ago Process Mechanical Engineer - Drinking Water (Western US)
Seattle, WA $97,000.00-$145,000.00 11 months ago Scientist - Upstream Process Development
Water + Wastewater Process Mechanical Engineer
Seattle, WA $95,000.00-$130,000.00 2 weeks ago Experienced Water / Wastewater Process Engineer
Seattle, WA $93,875.00-$140,870.00 2 days ago Senior Water + Wastewater Process Mechanical Engineer | PM
Microelectronics Process Engineer (Optical Products)
Sr. Process Development Engineer - Harnessing, Kuiper
Sr. Process Development Engineer - Harnessing, Kuiper
Redmond, WA $128,600.00-$213,600.00 2 weeks ago Process Mechanical Engineer - Water/Wastewater
Operations Engineer, Operations Engineering
Seattle, WA $54,600.00-$93,500.00 3 days ago Seattle, WA $117,498.00-$164,497.20 2 weeks ago Senior Photovoltaic Material and Process Development Engineer
Seattle, WA $140,959.00-$197,342.25 2 weeks ago Manufacturing Engineer, Battery Pack Testing, Project Kuiper
Redmond, WA $105,600.00-$185,000.00 3 days ago Senior Manager, Process Engineering Innovation, WW AMZL Process Engineering Innovation
Bellevue, WA $155,700.00-$269,100.00 10 hours ago Sr. Microelectronics Process Engineer (Optical Products)
Operations Engineer, Operations Engineering
Seattle, WA $68,900.00-$126,400.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr