Associate Director Process Engineering

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Job Description

You will oversee site Process Equipment and ensure it is 'fit for purpose' for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements. You will oversee strategic preparation of sites for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions. You will lead the development of system/equipment specifications. You will report to the Site Head of Engineering.

How you will contribute:

• You improve existing equipment to minimize production downtime. Provide leadership to all process equipment related investigations
• 'Factory Floor' Continuous Improvement / Trouble-shooting/ System ownership
• Provide leadership to all engineering disciplines during the development of the project requirements, design (concept, basic, and detail), timeline, and budget
• Develop and implement strategies to ensure cost and time designs while ensuring innovation and adhering to user requirements while managing daily operational support
• Guide Cross functional stakeholder management with our Partners in Manufacturing Sciences and Pharmaceutical Sciences. Lead the evaluation and selection of new, technologies and process equipment and applicable process equipment vendors (e.g.Robotics, Single Use Technology)
• Identify future industry trends and decide on strategies for process equipment/technologies.
• Manage business case development for CAPEX investments in process equipment incl. Total Cost of Ownership (TCO) calculations
• Manage Process Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility.
• Capacity Modeling and Site Master Planning
• Develop Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems
• Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common process engineering problems
• Lead Front End Engineering and Design activities in feasibility study and conceptual design phases
• Deliver Project Turnover Packages for Process Equipment delivered to site and ensure that critical engineering knowledge such as as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date
• Gather requirements from Team members - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS - to determine Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices
• Develop Scope of Work and RFx Packages for Process Equipment Vendors, Process Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors
• Lead commissioning activities such as Factory Acceptance and Site Acceptance Testing of process equipment
• With Partners in Engineering Validation deliver the Qualification and Validation activities for Process Equipment
• Manage Design Reviews of Process Equipment with Partners, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, and Automation
• Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems
• Perform Design Reviews of all process equipment with relation to EHS
• Oversee Investigations for process equipment and implement Corrective and Preventive Actions (CAPA)
• 'Factory Floor' Continuous Improvement/ Trouble-shooting/ System ownership
• Provide leadership of the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor
• Oversee continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and own level 3 troubleshooting in collaboration with 'Manufacturing' and Manufacturing sciences
• Responsible for Management of Change for Process Equipment. Responsible for internal and regulatory Audits and Inspections
• Engage in the Process Engineering Community of Practice (CoP) through sharing of best practices and lessons learned
• Determined basic causes and develop recommendations for corrective action, and follow-up to ensure completion of corrective action.
• Enable capabilities to perform troubleshooting on process equipment and systems
• 'Factory Floor' Continuous Improvement/ Trouble-shooting/ System ownership
• Provide leadership to analyze customer service problems and design improvement suggestions / decisions. Recommend design improvements through adaptations and modifications of standard technical principles.
• CAPEX Project Teams, Manufacturing Sciences, Quality, Manufacturing / Production, Utilities/Facilities Operations, Plant/Facilities/Utilities Engineering, Reliability Engineering, Maintenance, Calibration, Automation, EHS, Procurement / Purchasing, Equipment Vendors, Architectural / Engineering Services Companies, (Sub-) Contractors, Consultants
• Assess, analyze, advise, propose and direct improvements to deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department
• Ensure compliance to all regulatory GMP, Safety and Environmental requirements
• Shall work with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits and shall be able to defend current practices to such agencies.

What you bring to Takeda:

• Engineering degree or equivalent required; for example Chemical, Biochemical, Mechanical or Industrial engineering
• Minimum 8 years of relevant experience
• Expert of Process Unit Operations in Pharmaceutical Manufacturing
• Experience supporting CAPEX project delivery and equipment acquisition processes.
• Experience applying process improvement methodologies such as DMAIC and Root Cause Analysis (RCA), and tools such as Failure Mode And Effects Analysis (FMEA)
• Understanding of Good Manufacturing Practices (GMP)
• Experience leading expert for e.g statistical data analysts and data visualization tools
• Experience overseeing of all machines/lines/systems and all of its components.
• SME of Process Unit Operations in Pharmaceutical Manufacturing
• Expert of CAPEX project delivery and equipment acquisition processes

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range:

Kristin Test
$149,100.00 - $255,600.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time