Looking to leverage your extensive background in the installation, testing, turnover and operations of laboratory and process equipment as a key resource in multi-million dollar Biotech projects? We are seeking an experienced Process/Lab Equipment SME to support large-scale CapEx projects within the Biotech industry.
Here's a taste of what you'll be doing: - 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 related disciplines.
- 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 leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.
- Extensive experience related to GMP process and lab equipment.
What TAI offers: - The opportunity to make a real impact on a variety of industry-leading projects.
- The ability to balance your work and family activities.
- Work in a dynamic and collaborative environment that values creativity and innovation.
- Competitive salary and benefits package.
- A chance to learn and grow alongside some of the brightest minds in engineering.
- Professional Development and Association Membership Reimbursements - such as ISPE Membership.
Additional Offering: - Competitive salary offering ($110k - $150k).
- 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.
