Lab Equipment SME

Are you a Lab Equipment SME looking for an opportunity to join a renowned design-build firm? We have an immediate need for Lab Equipment SME to be involved in facility startup/operational readiness, day-to-day operational matters, and preventive/corrective maintenance activities.

Here's a taste of what you'll be doing:

• Will assist the Facilities & Engineering management teams by serving as work package lead for all process and lab equipment within the Rockville facility.
• Provide equipment engineering services; development of asset Lifecyle plans, maintenance plans for preventative maintenance and calibrations, and design for equipment and/or facilities systems.
• The SME will focus on service contracts, inductions of direct impact equipment into SAP, etc.
• Author and support F&E procedures for process and lab equipment.
• Work with startup teams during the commissioning and validation phases of the project, ensuring clear communication and hand-off of information.
• Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality, Facilities and Engineering.
• Assure cGMP operations are executed in compliance with applicable guidelines and regulations.
• Responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans.
• Specify, procure and install new assets into the facility. Modify facilities as needed to support new assets including space planning and utility planning.
• Support investigation and identify root cause for critical equipment and determine CAPA.
• Work with vendors and corporate to define equipment requirements
• Write and review technical documentation.
• Executes change control and change management including cost and change justification.

You'll be a perfect fit if you have:

• Bachelor's degree in chemical, Mechanical or other applicable Engineering program.
• Five or more years of experience in GMP biologic/cell therapy manufacturing technical or process support.
• Proven success working in a regulated manufacturing environment in the Biotechnology, Pharmaceutical industry preferred.
• Strong collaborator with ability to create and maintain effective working relationships and willing to challenge behaviors and actions.
• Demonstrated practitioner of practical problem-solving.
• Detail focused completer/finisher with a results-orientated mindset.
• Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.
• Collaborate and work in partnership with multiple customer teams to deliver program/project objectives.
• High professional standards, holding themselves and others in the team to deliver high quality outcomes to committed deadlines.
• Works with integrity and tenacity to 'do the right thing' even under challenging situations.

Compensation and benefits offering:

• Pay: $100k - $125k a year (based on experience)
• Annual Profit Sharing Bonus (variable depending on firm's performance, employee performance, and tenure).
• PTO and paid holidays.
• Health benefits - Employee through family level coverage for medical, dental, and vision insurances. Company funded life and long-term disability insurances. Short Term Disability, FSA, HSA, EAP, and supplemental life insurances (employee - family) are also available!
• 401k with employer match.

If you're interested in learning more about TAI Engineering and what made us a top-20 partner to the manufacturing sector per Engineering News Record (ENR), please visit us at www.taiengineering.com.