Manufacturing Compliance Specialist

Actalent

  • Redmond, WA
  • $40.00-55.00 per hour
  • Permanent
  • Full-time
  • 2 days ago
Job Title: MSAT Process EngineerOur 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 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 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.
Pay and BenefitsThe pay range for this position is $40.00 - $55.00/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 TypeThis is a fully onsite position in Redmond,WA.Application DeadlineThis position is anticipated to close on Sep 16, 2025.About ActalentActalent 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 for other accommodation options.

Actalent