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TAI Lab Equipment SME in Rockville, Maryland

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.

TAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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