Engineering Technical Specialist

Job Title: Engineering Technical Specialist

Job Description

The Engineering Technical Specialist provides technical support for GMP and non-GMP operations, including Process Development, Clinical, and Manufacturing environments. This role is responsible for equipment validation, metrology, facilities maintenance, and electronic Quality Management System (eQMS) support to ensure equipment, systems, and procedures remain compliant, reliable, and operational. The position combines hands-on technical work, quality oversight, documentation development, and cross-functional collaboration to support manufacturing and facility operations in a regulated environment.

Responsibilities

- Develop and maintain validation and revalidation documentation, including User Requirements Specifications (URS), Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Execute validation protocols, investigate deviations and non-conformances, and prepare final validation reports.
- Coordinate validation activities with internal stakeholders and external vendors to ensure timely execution and documentation closure.
- Review and approve validation protocols, reports, and validation summary packages.
- Provide oversight and coordination of vendor qualification activities when required.
- Coordinate calibration schedules with equipment and system owners to maintain compliance.
- Review and approve vendor calibration and certification documentation.
- Investigate and resolve equipment excursions and out-of-tolerance conditions.
- Perform basic calibrations when required, including temperature, pressure, and humidity-related equipment.
- Create, manage, and execute preventive and corrective maintenance work orders.
- Review and approve contractor and vendor service reports and maintenance activities.
- Support troubleshooting efforts and respond to building and equipment alarms as needed.
- Maintain equipment and system lifecycle data within the electronic Quality Management System (eQMS).
- Support onboarding, qualification, decommissioning, and retirement of equipment and systems.
- Identify opportunities to improve equipment lifecycle management, reliability, and compliance.
- Collaborate with Quality, Engineering, Manufacturing, Facilities, and external service providers to support operational objectives.

Essential Skills

- Minimum of 3 years of experience in a GMP-regulated manufacturing environment.
- Experience supporting equipment validation, qualification, or requalification activities.
- Strong technical writing experience, including protocol and report generation.
- Knowledge of IQ/OQ/PQ documentation and validation methodologies.
- Experience working with electronic Quality Management Systems (eQMS).
- Exposure to metrology and calibration programs.
- Ability to manage multiple projects and priorities simultaneously.
- Strong problem-solving and investigation skills.
- Experience supporting regulated manufacturing, laboratory, or pharmaceutical operations.
- Excellent communication and cross-functional collaboration skills.

Additional Skills & Qualifications

- Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related scientific discipline.
- Experience within biotechnology, pharmaceutical, cell therapy, gene therapy, or medical device industries is preferred.
- Familiarity with FDA regulations, GMP requirements, and quality systems.
- Experience coordinating vendor support activities and contractor oversight.
- Understanding of facility systems and equipment maintenance processes.
- Ability to use basic hand tools and troubleshoot equipment issues.
- Experience reviewing calibration, maintenance, and qualification records.

Work Environment

This position is primarily based in a GMP manufacturing and laboratory environment supporting process development, clinical production, manufacturing operations, and facility systems. The role involves a combination of office-based documentation work and hands-on interaction with equipment, utilities, and facility infrastructure. Candidates should be comfortable working cross-functionally with Quality, Engineering, Manufacturing, and Facilities teams. The Engineering Technical Specialist will participate in an on-call rotation to support equipment and facility alarms. Team members rotate on-call responsibilities on a monthly basis. While support is available 24/7, the organization is not a fully commercial manufacturing operation, and many alarms can be assessed and addressed during normal business hours the following day when appropriate.

Physical Requirements

- Ability to lift up to 50 pounds.
- Ability to climb ladders and stairs.
- Ability to perform repetitive motion activities throughout the workday.
- Ability to work occasional evenings or weekends as needed.
- Ability to use basic tools and equipment safely and effectively.

Top Skills

- Equipment Validation (IQ/OQ/PQ)
- GMP Manufacturing
- Technical Writing & Protocol Development
- Metrology & Calibration Oversight
- Electronic Quality Management Systems (eQMS)
- Preventive & Corrective Maintenance
- Deviation Investigation & Resolution
- Cross-Functional Project Coordination

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 Oct 1, 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 [email protected] 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.