Engineering Technical Specialist

Job Title: Engineering Technical Specialist Job Description The Engineering Technical Specialist provides direct and indirect technical support for GMP and non-GMP operations, including process development, clinical, and manufacturing activities. This role focuses on validation, metrology, facilities maintenance, and electronic quality management systems to ensure equipment, systems, and quality procedures meet defined requirements and operate reliably and consistently. Responsibilities

- Develop comprehensive validation and revalidation documentation, including user requirements, risk assessments, and installation, operation, and performance qualification (IOPQ) protocols.
- Execute validation and revalidation protocols, document results, and address deviations and non-conformances in a timely and compliant manner.
- Prepare and finalize validation reports and summary packages that clearly demonstrate equipment and system performance against defined requirements.
- Coordinate validation activities with key stakeholders, including scheduling logistics, execution planning, and documentation closure.
- Review and approve validation protocols, reports, and summary packages to ensure technical accuracy and compliance with quality standards.
- Manage and provide oversight for vendor qualification activities, ensuring external partners meet required technical and quality criteria.
- Coordinate with system owners to maintain adherence to metrology and calibration schedules for critical equipment and instruments.
- Provide oversight of vendor calibration and certification activities, including review and approval of calibration and certification reports.
- Investigate and address out-of-calibration conditions and excursions, ensuring appropriate corrective actions and documentation.
- Perform simple calibrations, where applicable, for parameters such as temperature, pressure, and relative humidity using appropriate tools and methods.
- Develop, execute, and resolve work orders for corrective and preventive facilities maintenance to support reliable operation of equipment and building systems.
- Provide oversight of vendor and contractor service work orders, reviewing and approving documentation to confirm work quality and completion.
- Respond to building and equipment alarms as needed to maintain safe, compliant, and continuous operations.
- Provide technical support for the development and maintenance of equipment and system life cycles within the electronic quality management system (eQMS).
- Collaborate cross-functionally to onboard new equipment and systems and to decommission.
- Assess and evaluate opportunities to improve equipment and system life cycle management, recommending enhancements to processes and documentation.
- Support quality management activities related to equipment and facilities, including CAPA execution tied to work orders, alarms, and system performance.

Essential Skills

- Minimum of 3 years of experience in a GMP manufacturing environment.
- Strong expereince in equipment validation within GMP settings, including protocol development, technical writing, and execution of validation activities.
- Hands-on experience with metrology concepts, including calibrations and measurement of temperature, pressure, and relative humidity.
- Practical understanding of electronic quality management systems (eQMS) and their use in managing equipment and system life cycles.
- Demonstrated experience with facilities maintenance processes, including creating, executing, and closing work orders for corrective and preventive actions.
- Ability to respond to and troubleshoot equipment and building alarms in a manufacturing or laboratory environment.
- Knowledge of quality management principles, including CAPA processes and documentation requirements.
- Experience in cell or gene therapy manufacturing, or broader biotech manufacturing operations.
- Bachelors degree in a scientific or engineering discipline.
- Proficiency in technical writing, including clear and accurate documentation of protocols, reports, and quality records.
- Familiarity with GMP and non-GMP operational requirements and their impact on equipment and system management.

Additional Skills & Qualifications

- Experience working in cell therapy or gene therapy environments, with an understanding of specialized equipment and processes.
- Experience in biotech manufacturing, including exposure to process development and clinical manufacturing operations.
- Ability to manage and prioritize multiple validation, metrology, and maintenance activities in a dynamic environment.
- Strong cross-functional collaboration skills, with the ability to work effectively with system owners, quality, manufacturing, and external vendors.
- Detail-oriented approach to documentation, review, and approval of technical and quality records.
- Ability to identify opportunities for process improvement in equipment life cycle management and quality systems.
- Comfort working within an organization that is preparing for commercialization and public offering, with an interest in growth and long-term stability.

Work Environment This role operates in a GMP and non-GMP manufacturing and process development environment that supports cell and gene therapy and biotech operations. The position involves regular interaction with production equipment, facility systems, and quality management tools, including electronic quality management systems. The department is highly engaged in commercialization activities, offering long-term stability backed by an extended facility lease and potential equity participation through stock options as the organization moves toward going public. Physical requirements include the ability to move up to 50 pounds, climb ladders and stairs, and perform repetitive motion activities during working hours. The role may require occasional off-hours and weekend work to respond to alarms, support critical operations, or complete time-sensitive maintenance and validation tasks. The position also requires proficient use of basic tools and equipment commonly used in calibration, maintenance, and facility support activities, within a professional, safety-focused, and quality-driven environment.
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 16, 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.