Description

Position Summary:

The Master Equipment File (MEF) Specialist is responsible for the creation, management, and maintenance of comprehensive documentation packages for GMP-critical equipment and automated systems used in biopharmaceutical manufacturing. This includes maintaining equipment data integrity, lifecycle documentation, and integration with manufacturing execution systems. DeltaV Distributed Control System (DCS) experience is required for supporting documentation and configuration management across automated bioprocesses.

Key Responsibilities:

Develop and maintain Master Equipment Files (MEFs) for GMP equipment and process systems, including DeltaV-controlled assets.\\Ensure MEFs are compliant with regulatory standards (FDA, EMA, ICH Q9/Q10), internal SOPs, and industry best practices.Collaborate with Engineering, Automation, Manufacturing, and Quality teams to gather equipment specifications, validation data, and operational details.Support configuration documentation and change management related to Emerson DeltaV DCS, including process automation control strategies and system configuration records.Review and update equipment user requirements (URS), functional specifications (FS), and design specifications (DS) related to DeltaV and other automated systems.Support audits and inspections by maintaining complete and accurate documentation for GMP-critical systems and instrumentation.Track equipment lifecycle documents including commissioning, qualification (IQ/OQ/PQ), calibration, and maintenance records.Participate in deviation investigations, CAPAs, and change controls involving DeltaV-controlled equipment and automated processes.Ensure data integrity, traceability, and audit readiness of all equipment files and electronic records.Provide training and support to end-users and document owners on MEF expectations and document management systems.

Qualifications

Education:

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.Advanced degree or certifications (e.g., Six Sigma, CQE) a plus.

Experience:

3–5+ years of experience in GMP-regulated biopharmaceutical manufacturing, preferably in a CMO environment.Hands-on experience with DeltaV DCS in a GMP manufacturing setting (biologics or sterile manufacturing strongly preferred).Strong working knowledge of equipment qualification, automation systems documentation, and data integrity compliance.

Skills:

Proficiency in managing technical documentation and working within document management systems (e.g., Veeva, MasterControl, Documentum).Strong written and verbal communication skills with attention to detail.Ability to work cross-functionally in a dynamic, fast-paced, and regulated environment.Skilled in Microsoft Office Suite; knowledge of engineering drawing software or DeltaV Explorer a plus.

Preferred Experience:

Prior experience working at a CMO or CDMO with multiple client equipment configurations.Involvement in facility start-up, tech transfer, or equipment commissioning projects.Experience with cleaning validation documentation or single-use system integration.

Pay and Benefits

The 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 Type

This is a fully onsite position in Redmond,WA.

Application Deadline

This position is anticipated to close on Aug 22, 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.