Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Engineering Document Control Specialist
Location: Plainville, MA - 02762
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 08:00 AM to 05:00 PM
Summary:
Systems Verification and Validation Engineer/Scientist II / Engineering Document Control Specialist position serves as the primary liaison between Facilities Engineering and cross-functional stakeholders, including Project Management, Validation, and Quality. The role is responsible for ensuring that all engineering documentation, drawings, and records comply with cGMP and site quality requirements. The position focuses on maintaining accurate, controlled, compliant, and inspection-ready GMP and non-GMP documentation while supporting engineering systems, document control processes, contractor compliance, and regulatory inspections within a biopharmaceutical manufacturing environment.
Responsibilities
- Serve as the primary Engineering Documentation point of contact for Project Management, Validation, and Quality teams.
- Develop, implement, and manage procedures and periodic review schedules for GMP As-Built and Non-GMP Master Drawings.
- Maintain and control the master inventory of GMP and Non-GMP engineering drawings in both electronic and hard-copy formats using the Adept Documentation System.
- Manage CAD services through the Adept CAD system and ensure drawing accuracy, revision control, and compliance.
- Support internal audits and regulatory cGMP inspections by maintaining inspection-ready documentation.
- Oversee project contractors to ensure adherence to site documentation standards and engineering documentation requirements.
- Support deviation investigations, CAPAs, and Change Control activities, including documentation updates and implementation.
- Manage EDMS workflows, including document routing, review, approval, and archival processes.
- Update and maintain CMMS work orders related to engineering drawings and documentation.
- Support spare parts programs, utility system documentation, and engineering record management.
- Perform additional duties and projects assigned by Facilities & Engineering leadership.
Required Skills
- Bachelor's degree in a technical discipline or related field (preferred).
- Minimum 3 years of experience in CAD drafting and engineering documentation within a regulated industry.
- Experience maintaining engineering drawings, as-built drawings, and controlled engineering documentation.
- Knowledge of cGMP regulations and quality systems within a pharmaceutical or biopharmaceutical manufacturing environment.
- Knowledge of local, federal, and regulatory requirements related to engineering documentation and manufacturing operations.
- Experience with Electronic Document Management Systems (EDMS).
- Experience with Computerized Maintenance Management Systems (CMMS); Blue Mountain experience preferred.
- Proficiency with CAD software and engineering documentation systems, including Adept CAD and Adept Documentation Systems.
- Experience supporting deviations, CAPAs, and Change Control processes.
- Strong understanding of document control procedures, inspection readiness, and compliance requirements.
- Ability to coordinate multiple projects, prioritize tasks, and meet deadlines in a fast-paced technical environment.
- Strong written and verbal communication skills.
- Strong interpersonal and stakeholder management skills.
- Ability to work independently and manage multiple concurrent priorities.
- High level of professionalism, integrity, and ethical conduct.
- Ability to read, write, and review technical documentation for extended periods.
- Proficiency with daily computer-based work and documentation systems.
- Ability to aseptically gown and/or sterile gown when required.
- Ability to wear Personal Protective Equipment (PPE).
- Ability to lift up to 50 pounds and perform routine physical activities, including climbing stairs, walking, reaching, kneeling, and crouching.
- Ability to meet vision requirements including close vision, distance vision, color vision, depth perception, peripheral vision, and focus adjustment.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.