Manufacturing Document Control Specialist

TekWissen LLC

Plainville, MA

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JOB DETAILS

SALARY

$30–$34

SKILLS

Biotech and Pharmaceutical, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Change Control, Communication Skills, Computerized Maintenance Management System (CMMS), Cross-Functional, Current Good Manufacturing Practice (cGMP), Document Control, Document Management, Documentation, Documentation Standards, Drug Manufacturing, Engineering Drawing, Establish Priorities, Facilities Engineering, Federal Laws and Regulations, GMP (Good Manufacturing Practices), Healthcare, Internal Audit, Interpersonal Skills, Inventory Management, Laboratory Equipment, Leadership, Leading Edge Technology, Lift/Move 50 Pounds, Maintain Compliance, Manufacturing, Manufacturing Operations, Multitasking, Organizational Skills, Presentation/Verbal Skills, Procedure Implementation, Product Development, Project Tracking, Project/Program Coordination, Project/Program Management, Purchasing/Procurement, Regulations, Regulatory Compliance, Regulatory Requirements, Scientific Research, Source Code/Configuration Management (SCM), Support Documentation, System Validation, Systems Engineering, Technical Support, Technical Writing, Time Management, Verification Engineering, Workforce Management, Writing Skills

LOCATION

Plainville, MA

POSTED

1 day ago

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.

About the Company

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Computer/IT Services

FOUNDED

2009

WEBSITE

http://www.tekwissen.com/

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