1 Shimadzu Scientific Instruments jobs in Columbia
Process/Lab Equipment SME
20851 Rockville, Maryland
TAI
Posted 3 days ago
Job Viewed
Job Description
**About the Role:**
We are seeking an experienced Process/Lab Equipment SME to support large-scale CapEx projects within the Biotech industry.
**About TAI:**
TAI has been a leading multidisciplinary firm for over 35 years, providing expert engineering, management, and technical services to industrial, manufacturing, commercial, and mission critical. With over 300 skilled professionals, 16 different divisions, and 6 offices across the US, TAI offers sole-source solutions for complex projects, built on long-term client partnerships and a culture that attracts top talent.
Team members at TAI are capable, well-rounded, flexible, and optimistic. We have found that the best employees are the ones who recognize the importance of what they do and the ones who let that guide them in the actions they take. More than any skill, we seek people who make decisions that support the common good. We work for our clients, and we work for one another.
**Here's a glimpse into your day to day:**
+ 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.
**Compensation and Benefits:**
+ 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.
**Other Offerings:**
+ The opportunity to make a real impact on a variety of industry-leading projects.
+ The ability to balance your work and family activities.
+ Flexible work schedule.
+ Work in a dynamic and collaborative environment that values creativity and innovation.
+ A chance to learn and grow alongside some of the brightest minds in engineering.
+ Professional Development, Tuition Reimbursement, and Association Membership Reimbursements.
Discover what makes TAI a top-20 manufacturing partner, according to _Engineering News-Record_ (ENR), and one of the top-50 fastest-growing private companies in the _Baltimore Business Journal_ . Learn more about us at ** .
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.
We are seeking an experienced Process/Lab Equipment SME to support large-scale CapEx projects within the Biotech industry.
**About TAI:**
TAI has been a leading multidisciplinary firm for over 35 years, providing expert engineering, management, and technical services to industrial, manufacturing, commercial, and mission critical. With over 300 skilled professionals, 16 different divisions, and 6 offices across the US, TAI offers sole-source solutions for complex projects, built on long-term client partnerships and a culture that attracts top talent.
Team members at TAI are capable, well-rounded, flexible, and optimistic. We have found that the best employees are the ones who recognize the importance of what they do and the ones who let that guide them in the actions they take. More than any skill, we seek people who make decisions that support the common good. We work for our clients, and we work for one another.
**Here's a glimpse into your day to day:**
+ 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.
**Compensation and Benefits:**
+ 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.
**Other Offerings:**
+ The opportunity to make a real impact on a variety of industry-leading projects.
+ The ability to balance your work and family activities.
+ Flexible work schedule.
+ Work in a dynamic and collaborative environment that values creativity and innovation.
+ A chance to learn and grow alongside some of the brightest minds in engineering.
+ Professional Development, Tuition Reimbursement, and Association Membership Reimbursements.
Discover what makes TAI a top-20 manufacturing partner, according to _Engineering News-Record_ (ENR), and one of the top-50 fastest-growing private companies in the _Baltimore Business Journal_ . Learn more about us at ** .
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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