Job Title: Manufacturing Technical SpecialistJob Description
The Manufacturing Technical Specialist supports the Process Compliance team and the wider manufacturing organization by driving business process improvements that enhance operational performance and customer satisfaction. This role focuses on improving quality, process capability, reliability and robustness, operational efficiency, and standard work within aseptic operations. The specialist provides technical leadership across product transfers, new equipment and process start-up, process optimization, and structured problem-solving to ensure efficient, compliant, and reliable manufacturing operations.
Responsibilities
Support the Process Compliance team and broader manufacturing organization by leading business process improvements that enhance quality, process capability, reliability, robustness, operational efficiency, and standard work.
Manage key operational support activities related to product transfers and new equipment or process start-up, including manufacturing readiness assessments, process design documentation, engineering runs, and equipment setup.
Perform critical technical and operational review and approval of documentation related to the design, validation, operation, and maintenance of manufacturing processes, equipment, and facilities, including engineering changes, document revisions, and validation documentation.
Drive process optimization initiatives within aseptic operations to significantly improve operational performance, process capability, and robustness.
Provide technical support for projects related to manufacturing operations and frontline execution, ensuring that processes run efficiently and in compliance with regulatory and quality requirements.
Own and actively manage planned events, CAPAs, and actions related to operational activities, procedures, and processes, ensuring compliance with internal standards and external regulations.
Conduct thorough technical and operational reviews and approvals for quality records, training materials, and documentation associated with process improvements, engineering changes, process design, and validation activities.
Own and actively manage deviations, ensuring timely documentation, investigation, and closure in alignment with quality and regulatory expectations.
Lead and facilitate Root Cause Analysis (RCA) and structured problem-solving events to investigate unplanned or unexpected events and define effective remediation actions.
Develop and pursue remediation plans that reduce the number of repeat and recurring events, strengthening overall process reliability and compliance.
Implement process improvement projects that significantly enhance performance and compliance in the areas of quality, process capability, process reliability, and operational efficiency.
Collaborate with cross-functional teams, including operations, quality, engineering, and compliance, to align technical changes and process improvements with business and regulatory requirements.
Ensure that technical changes, training plans, and process modifications are fully implemented, effective, and documented in accordance with regulatory and quality system expectations.
Essential Skills
Bachelor's degree in life sciences, physical sciences, engineering, or an equivalent combination of education and at least 2 years of relevant work experience.
Demonstrated ability to troubleshoot and resolve process-related issues while maintaining efficient operations and regulatory compliance.
Working knowledge of scientific and engineering principles relevant to aseptic process equipment, including isolators, filling machines, inspection equipment, packaging machines, and sterilization systems.
Understanding of regulatory requirements associated with aseptic manufacturing processes, equipment, and materials.
Working knowledge of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing.
Knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance in a manufacturing environment.
Experience implementing technical changes, including comprehensive implementation plans for training, documentation, and process changes to ensure they meet intended purposes and regulatory requirements.
Experience managing deviations, conducting root cause analysis, and developing remediation plans that effectively reduce repetition and recurrence.
Proven track record of implementing process improvement projects that enhance quality, process capability, reliability, and operational efficiency.
Experience working in laboratory, GMP, or quality control environments, with an understanding of good manufacturing practices.
Additional Skills & Qualifications
Ability to lead and facilitate structured problem-solving and Root Cause Analysis activities across cross-functional teams.
Strong analytical and critical thinking skills, with the ability to interpret complex technical and quality data to drive decisions.
Effective communication skills, with the ability to present technical information clearly to both technical and non-technical stakeholders.
Strong organizational skills and attention to detail, particularly in managing documentation, quality records, and change control activities.
Ability to work collaboratively in a multidisciplinary environment, partnering with operations, quality, engineering, and compliance teams.
Adaptability and willingness to support new technologies, equipment, and processes as manufacturing capabilities evolve.
Work Environment
The role operates within a regulated aseptic manufacturing environment that emphasizes quality, safety, and compliance with GMP standards. You will work closely with laboratory, production, engineering, and quality control teams, frequently engaging with aseptic process equipment such as isolators, filling lines, inspection systems, packaging machines, and sterilization systems. The work involves regular review of technical and quality documentation, participation in investigations and improvement projects, and support of frontline manufacturing activities. The environment is structured and process-driven, with established procedures and standard work guiding daily operations, and may require adherence to cleanroom and aseptic gowning protocols appropriate for biologics and sterile manufacturing settings.
Job Type & Location
This is a Contract position based out of Hillsboro, OR.
Pay and Benefits
The pay range for this position is $22.00 - $28.00/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 Hillsboro,OR.
Application Deadline
This position is anticipated to close on Aug 27, 2026.
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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
