Systems Engineer

Job Title: Systems Verification and Validation Engineer/Scientist II
Job Description
The Systems Verification and Validation Engineer/Scientist II serves as the primary liaison between Facilities Engineering and cross-functional partners in Project Management, Validation, and Quality. This role ensures that all engineering documentation and drawings meet current Good Manufacturing Practice (cGMP) and site quality requirements, remain accurate and controlled, and are always inspection ready. The position also oversees spare parts documentation, supports utility systems documentation, and ensures that contractors and internal teams follow established documentation standards in a highly regulated biopharmaceutical manufacturing environment.
Responsibilities

• Serve as the primary Engineering Documentation interface for Project Management, Validation, and Quality, ensuring clear communication and alignment on documentation needs and standards.
• Develop, implement, and manage procedures and periodic review schedules for GMP As-Built and non-GMP master drawings to maintain accuracy and compliance.
• Maintain a master inventory of GMP and non-GMP drawings in both electronic and hard copy formats using the Adept Documentation System.
• Manage CAD services using the Adept CAD system, ensuring that all drawings are accurate, up to date, and compliant with internal standards and regulatory expectations.
• Ensure that GMP and non-GMP drawings and engineering records are accurate, controlled, compliant, and inspection ready at all times.
• Support internal and external cGMP and regulatory inspections by maintaining audit-ready documentation and promptly addressing documentation-related requests.
• Provide oversight to project contractors to ensure adherence to site documentation standards, procedures, and quality expectations.
• Support deviations, CAPAs, and change controls, including preparation, routing, documentation, and implementation activities related to engineering documentation.
• Manage electronic workflows for document routing, review, and approval to ensure timely and compliant processing of controlled documents.
• Update and maintain Computerized Maintenance Management System (CMMS) work orders related to engineering drawings, with preference for experience using Blue Mountain.
• Provide oversight of documentation processes related to spare parts programs and utility systems to ensure accuracy and traceability.
• Coordinate and prioritize documentation activities to meet project milestones and timelines in a highly technical, results-oriented environment.
• Perform additional responsibilities as assigned by Facilities and Engineering leadership to support departmental and site objectives.

Essential Skills

• Minimum of three (3) years of experience in CAD drafting and engineering documentation within a regulated industry.
• Working knowledge of cGMP requirements and quality systems in a biopharmaceutical or similarly regulated manufacturing environment.
• Knowledge of cGMPs, local and federal regulatory requirements, and documentation procedures relevant to a biopharmaceutical manufacturing plant.
• Proficiency in CAD drafting and managing facility layout drawings.
• Experience with electronic document management and controlled documentation systems, including EDMS and the Adept Documentation System.
• Experience with CMMS systems, with Blue Mountain strongly preferred.
• Ability to coordinate and prioritize multiple tasks to meet milestones and timelines in a fast-paced, technical environment.
• Strong understanding of applicable regulatory requirements and their impact on engineering documentation and records management.
• Strong interpersonal and communication skills, both written and oral, to effectively collaborate with cross-functional teams and contractors.
• Ability to write, read, and review technical documentation for extended periods with high attention to detail.
• Ability to aseptically gown and/or sterile gown as needed to access controlled production or utility areas.
• Ability to ascend and descend stairs approximately 20% of the time, lift up to 50 pounds, and sit for up to 4 hours at a time.
• Ability to occasionally lift, walk, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch as required by the role.
• Specific vision capabilities including close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Comfort working with daily computer use and digital systems in an office and manufacturing support setting.

Additional Skills & Qualifications

• Bachelor's degree in a technical or related field is preferred.
• Experience managing CAD services and documentation using the Adept CAD system.
• Experience with document control processes and workflows in a regulated environment.
• Familiarity with facility layout drawings and engineering documentation for utilities and manufacturing systems.
• Ability to work comfortably on concurrent issues and projects in an ambitious, fast-paced environment.
• High ethical standards and a strong commitment to professional business conduct in handling documentation and regulatory requirements.
• Demonstrated ability to work collaboratively with cross-functional teams, including Facilities Engineering, Project Management, Validation, Quality, and external contractors.

Work Environment
This role operates in a biopharmaceutical manufacturing support environment that combines office-based work with regular access to production, utility, and facility areas. The position involves daily computer use for CAD drafting, document management, and interaction with systems such as Adept, EDMS, and CMMS (Blue Mountain preferred). The work requires extended periods of reading, writing, and reviewing technical documentation, as well as frequent coordination with cross-functional teams. Physical activities may include ascending and descending stairs approximately 20% of the time, lifting up to 50 pounds, and occasionally walking, reaching, handling materials, and stooping, kneeling, or crouching. The role requires specific vision capabilities, including close and distance vision, color perception, peripheral vision, depth perception, and the ability to adjust focus, to accurately review drawings and documentation. The position may require aseptic or sterile gowning to enter controlled areas and mandates the use of appropriate Personal Protective Equipment (PPE) in accordance with site safety and quality procedures. The work schedule follows a standard Sunday-Saturday coverage model typical for contingent roles in a dynamic, fast-paced, and highly regulated manufacturing environment.
Job Type & Location
This is a Contract position based out of Plainville, MA.
Pay and Benefits
The pay range for this position is $38.00 - $40.00/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 Plainville,MA.
Application Deadline
This position is anticipated to close on Jul 3, 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 View email address on click.appcast.io 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.