Description The Engineering Technical Specialist will provide direct/indirect technical support for GMP and NonGMP operations (Process Development, Clinical, and Manufacturing operations). The role encompasses validation, metrology and facilities maintenance for various equipment/systems. The candidate performs quality functions to ensure that equipment/systems and quality procedures adhere to system requirements and can perform properly and consistently.

Key Responsibilities:

• Validation/Revalidation (25%) o Develop documentation related to validation/re-validation.

These include but are not limited to User Requirements, Risk Assessments, Installation, Operation and Performance protocol (IOPQ) o Execute protocols, address deviations/non-conformance, and develop final reports for executed protocols. o Coordinate with key stakeholders on scheduling logistics, execution and documentation closure. o Review/approve protocols, reports and validation summary packages o Where applicable, manage and provide oversight on vendor qualification support.

• Metrology (25%) o Coordinate with system owners to ensure schedule adherence o Provide oversight on vendor calibration/certification activities o Review and approve calibration/certification reports o Address relevant out-of-calibration and/or excursions o Where applicable, perform simple calibration that includes but not limited to temperature, pressure and relative humidity.
• Facilities Maintenance (25%) o Develop, execute and address work orders (corrective and preventive) o Provide oversight, review and approve vendor/contractor service work orders o Respond to building/equipment alarms as needed
• Electronic Quality Maintenance System (eQMS Maintenance) (25%) o Provide technical support to develop and maintain equipment/system life cycle.

o Work cross-functionally to onboard and offboard equipment/systems o Assess and evaluate opportunities to enhance equipment/system life cycle Skills Validation, Metrology, QMS, Quality Management, GMP, Manufacturing, Technical Writing, cell therapy, Work Orders, Facilities Maintenance, Gene Therapy, Biotech manufacturing, CAPA Top Skills Details Validation,Metrology,QMS,Quality Management,GMP,Manufacturing,Technical Writing Additional Skills & Qualifications 1. Facilities Maintenance (work orders, CAPAs, equipment alarms) 2. Cell/ Gene Therapy manufacturing experience (or biotech) Experience Level Intermediate Level Job Type & Location This is a Permanent position based out of Gaithersburg, MD. Pay and Benefits The pay range for this position is $85000.00 - $110000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Insurance & 401k, there will likely be a match by EOY. Workplace Type This is a fully onsite position in Gaithersburg,MD. Application Deadline This position is anticipated to close on Sep 30, 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.