Document Control Assistant Jobs in Columbia, SC (NOW HIRING)

Description

Job Purpose: 

The Senior Engineering Associate provides technical and engineering support to the Manufacturing Science & Technology (MS&T) group, with primary responsibility for maintaining and controlling facility and engineering CAD drawings, supporting cleanroom construction activities, and assisting with capital and site improvement projects. This role serves as a key resource for engineering documentation, facility modifications, equipment installations, and project execution while ensuring compliance with cGMP requirements and internal quality standards. The position collaborates closely with Engineering, Validation, Quality, Manufacturing, and external contractors to support facility reliability, expansion initiatives, and operational excellence.

Essential Duties and Responsibilities:

Maintain, revise, and control facility, utility, process, and equipment CAD drawings in accordance with document control procedures.

Develop and update engineering drawings, layouts, P&IDs, equipment arrangements, and as-built documentation for facility and process changes.

Support cleanroom construction, renovation, and expansion projects, including coordination with contractors, vendors, and internal stakeholders.

Assist with planning, execution, and closeout of capital projects, facility upgrades, and equipment installations.

Participate in project design reviews and provide technical input for facility and process improvements

Participate in the planning, development, and execution of engineering and process improvement initiatives

Assist with the design, fabrication and integration of prototype components, tooling, and equipment

Assist with procurement, installation, commissioning, and startup activities for new equipment and systems.

Assist in troubleshooting activities across the facility

Participate with preventative maintenance strategies and assist in maintaining plant equipment

Assist with procurement, installation, and commissioning of new equipment

Maintain engineering records, project files, and technical documentation in accordance with company procedures.

Participate in contractor management activities, including scheduling, oversight, and verification of completed work.

Develop, execute and document process development and validation protocols

Prepare and revise technical documentation (SOPs, protocols, reports, change controls)

Ensure all stability equipment operations comply with cGMP and internal procedures

Oversee calibration and validation activities for stability chambers

Maintain inventory of stability equipment, spare parts and critical components

Oversee equipment qualification and requalification activities for stability chambers and related systems

Requirements

Experience:

5-7 years Pharmaceutical and/or Manufacturing experience

Proficient in Microsoft Office Suite with a strong knowledge in Word and Excel

Highly organized with the ability to manage multiple projects and changing priorities

Ability to work well independently or with a team

Advanced proficiency with AutoCAD and/or other CAD software required.

Experience supporting facility, utility, cleanroom, or capital construction projects preferred.

Willingness to participate in ongoing training and professional development opportunities.

Strong understanding of facility systems, equipment layouts, and engineering drawing standards.

Possess a strong attention to detail

Knowledge of cGMP plant operations and scale-up is desired

The ability to motivate and influence others, thinks globally and leverages diversity

The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals

Willingness to participate in training and gain other education and or certifications as needed

Working Conditions / Physical Requirements:

Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, hearing, sitting, typing, and walking

     Ability to work in cleanroom environments, including gowning requirements