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Manufacturing Technical Specialist

inSync Staffing

  • Hillsboro, OR
  • 1 day ago
  • $28–$28.74 Per Hour

Highlights

This role oversees technical changes, manages deviations and CAPAs, facilitates root cause analyses, and provides operational support for new capabilities, equipment start-ups, and product transfers in a regulated biopharmaceutical environment. Job Specifications: Support new capabilities and tech transfers by managing operational readiness, process design, engineering runs, document changes, and equipment setup.

Numbers & Facts

LocationHillsboro, OR
IndustryStaffing/Employment Agencies
Salary$28–$28.74 Per Hour
Company Size50 to 99 employees
Year Founded2014
Websitehttp://www.insyncstaffing.com/default.html

Description

Job Title: Manufacturing Technical Specialist
Location: Hillsboro, OR 97124
Pay Rate: $28.00 - $28.74 / Hour
Work Schedule: Monday - Friday, Full-Time (Onsite)
Job Overview:
The Manufacturing Technical Specialist supports the Process & Compliance team and the broader HTO Manufacturing organization by driving business process improvements that significantly enhance operational performance, quality, process capability, process reliability, and standard work within Aseptic Operations. This role oversees technical changes, manages deviations and CAPAs, facilitates root cause analyses, and provides operational support for new capabilities, equipment start-ups, and product transfers in a regulated biopharmaceutical environment.
Job Specifications:
  • Support new capabilities and tech transfers by managing operational readiness, process design, engineering runs, document changes, and equipment setup.
  • Conduct technical and operational reviews and approvals for documentation related to the design, validation, operation, and maintenance of manufacturing processes, equipment, and facilities.
  • Drive business process optimization and reliability initiatives to improve operational performance and frontline execution within Aseptic Operations.
  • Own and actively manage technical changes, planned events, CAPAs, and remediation actions related to operational procedures and regulatory compliance.
  • Lead and facilitate Root Cause Analysis (RCA) and structured problem-solving events for unexpected deviations to prevent repeat occurrences.
  • Evaluate training plans, document revisions, and process updates to ensure alignment with operational needs and cGMP regulatory standards.
  • Collaborate cross-functionally across manufacturing, quality, engineering, and validation teams to maintain robust aseptic processing operations.
Qualifications and Experience:
  • Minimum of 2 years of work experience in aseptic processing, manufacturing, and validation environments.
  • Working knowledge of scientific and engineering principles relevant to aseptic processes and equipment (e.g., isolators, filling machines, inspection/packaging machines, sterilization systems).
  • Thorough understanding of aseptic processing principles, biologics manufacturing regulations, quality systems, microbiology, and sterility assurance.
  • Proven track record in structured problem-solving, root cause analysis, and deviation investigation.
  • Experience developing and executing technical change implementation plans, including training and document controls.
  • Strong troubleshooting abilities to resolve process-related issues while maintaining regulatory compliance.
  • Requirement: Must be local to Hillsboro, OR (onsite position).
Education Requirements:
  • Bachelor’s degree from an accredited college or university in Life Sciences, Physical Sciences, Engineering, or an equivalent combination of education and relevant work experience.
Benefits:
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

About Company

We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible. inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced. The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.

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