Engineering Document Control Specialist
Job Location:
Job Location:
Plainville, CT - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
6 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 clients 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
- Bachelors 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.
