Process Engineering - Life Sciences - Division Manager

TAI; Newark (DE); Ibrido; USD 140.000 - 185.000; Tempo pieno

Vantaggi offerti da questo lavoro

Overtime pay

Profit sharing bonus

Paid time off and holidays

Health benefits

Descrizione del lavoro

TAI seeks a Division Manager to lead the Process Engineering - Life Sciences Division, guiding engineers and designers, and driving complex project delivery for pharmaceutical and biotech clients.

You will oversee operations, ensure GMP compliance, manage budgets and schedules, mentor staff, and contribute to business development while traveling to client sites as needed.

Competenze

• Must have 13+ years of process engineering in life sciences/pharma with GMP knowledge.
• Experience designing life sciences/pharma projects including process/utilities systems.
• Proven ability to mentor staff and lead teams on complex projects.
• Strong understanding of FDA/EU regulations and cGMP guidelines.
• Ability to develop PFDs, P&IDs, and equipment specifications.
• Willingness to travel to client sites and work on-site two days per week.

Mansioni

• Oversee divisional operations, ensuring compliance with corporate standards.
• Provide leadership and SME input for process life sciences projects.
• Manage budgets, schedules, and quality across the division.
• Staff management, training, mentoring, and career development.
• Support business development with site walks and scope/fee development.
• Maintain client relationships and ensure professional conduct.
• Coordinate with other division managers on processes and standards.
• Lead regulatory code interpretation and GMP compliance efforts.
• Prepare detailed engineering analyses, studies, and reports.

Conoscenze

Leadership

GMP knowledge

Process life sciences

Project delivery

Client relationship management

Mentoring staff

Regulatory awareness

Communication skills

Travel readiness

Field work capability

Formazione

Bachelor’s degree in Chemical/Mechanical Engineering or related field

Master’s degree in biotechnology or related field

Professional Engineering Licensure

NCEES Model Law Engineer preferred

NCEES Records holder preferred

13+ years process engineering experience in life sciences/pharma

5+ years design experience in consulting engineering

Strumenti

PFDs

P&IDs

URS development

GMP equipment lists

Descrizione del lavoro

About The Role

Lead and shape the future of TAI's Process Engineering - Life Sciences Division. As Division Manager, you’ll guide a talented team of engineers and designers, oversee complex project delivery, and drive the strategic growth of a high performing division. This position places you at the center of developing innovative process solutions for pharmaceutical and biotech clients, blending technical direction, operational oversight, and hands on subject matter expertise. You’ll influence project outcomes, strengthen client relationships, and collaborate across disciplines to elevate engineering standards and deliver impactful results in a rapidly evolving industry.

About TAI

TAI brings together engineering, construction, systems integration, on-site services, and technical services — combining proven execution with trusted expertise to support clients across the entire project lifecycle. 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

• Oversee and manage divisional operations, ensuring compliance with corporate standards and policies.
• Provide strong leadership and deep, practical process life sciences and GMP process engineering knowledge.
• Bring knowledge and creativity to the position as well as having the discipline to drive results and follow established fundamental processes.
• Responsible for quality, budget, and schedule performance of divisional operations.
• Responsible for staff management, engagement, training, mentoring and career growth.
• Responsible for project resource management and ensuring projects are staffed with personnel having appropriate qualifications to perform assigned tasks.
• Responsible for ensuring quality control policies are being adhered to.
• Responsible for conducting annual and quarterly employee reviews and completion of HR documentation.
• Responsible for business development support, including site walks and engineering design scope and fee development, with a focus on pharmaceutical manufacturing and facility design opportunities, providing early engineering input on process design, equipment selection, and GMP compliance as needed.
• Responsible for relationship management of existing clients.
• Responsible for relating to employees and clients in a mature and professional manner.
• Responsible for compliance with corporate safety policies and procedures.
• Responsible for coordination and collaboration with other division managers for engineering processes and standards.
• Responsible for functioning as Subject Matter Expert (SME) for process life science projects.
• Responsible for researching applicable regulatory codes, industry guidelines and standards.
• Responsible for interpreting codes and collaborating with other design professionals as needed.
• Responsible for preparing detailed engineering analysis, studies, and reports.

You’ll Be a Perfect Fit If You Have

• Bachelor’s degree from an accredited university in Chemical Engineering, Mechanical Engineering, or related engineering field.
• Master’s degree in biotechnology or similar focus is preferred.
• Professional Engineering Licensure.
• NCEES Model Law Engineer is preferred.
• NCEES Records holder is preferred.
• Minimum 13 years of process engineering experience within the life sciences/ pharmaceutical industry. This includes experience with pharmaceutical manufacturing and equipment, FDA and EU regulations, and cGMP guidelines.
• Minimum 5 years of applicable design experience within a consulting engineering firm. Applicable design experience includes creating construction documents and specifications for life sciences/pharmaceutical projects involving process and/or utility systems and equipment.
• Minimum 5 years of experience developing PFD’s, P&ID’s, equipment and piping specifications.
• Ability to act as Subject Matter Expert (SME) for life sciences process and/or utility systems.
• Knowledge and experience with pharmaceutical process validation and quality control is preferred.
• Understanding of pharmaceutical safety protocols and risk management processes is preferred.
• Experience with the following equipment and related systems (design experience preferred):
  • Proficiency with GMP process utilities, including USP purified water, Water for Injection, Process/Biowaste, process gases and liquid nitrogen.
  • Familiarity with process equipment, including bioreactors, mixers, chromatography systems, filtration skids, single-use equipment, viral inactivation, incubators, washers, sterilizers, and controlled temperature units (-20°C freezers, -80°C freezers, and cryogenic freezers).
  • Proficiency with Process Flow Diagrams (PFDs), P&IDs, and piping specifications.
  • Proficiency with User Requirement Specifications (URS).
  • Developing GMP Equipment lists.
  • Determining process utility requirements.
  • Sizing, specification and layout of process utility equipment.
  • Planning, organizing, and preparing GMP process layouts for pharmaceutical and cell therapy manufacturing facilities is preferred.
  • Support for commissioning and qualification of equipment, utility systems and facilities, including IQ, OQ, and PQ is preferred.
• Ability to perform field work
• Willingness to travel to client sites.
• Willingness to work in the office at least two days per week.
• Ability to gather and organize information and documentation.
• Ability to multitask
• Ability to mentor staff
• Excellent verbal and written communication skills, a positive work attitude, and willingness to learn new skills.

Compensation And Benefits

• Pay: $140,000-185,000 annually (depending on experience)
• Eligible for overtime pay
• Annual Profit Sharing Bonus (variable)
• 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!
• 401(k)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 www.tai.inc/.