Process Engineer II
Social Circle, Georgia
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.
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Engineer II job description
The individual will be expected to monitor and provide support for manufacturing operations. Responsibilities will include attending manufacturing morning meetings, daily production data trend review, event response and troubleshooting, batch review, deviation initiation support, and manufacturing personnel training. The individual will also be responsible for sampling and/or testing protocol authoring and review, as well as SOP and batch record review. Leadership and guidance of junior staff members in certain situations will also be expected.
- 50% Floor Support - Support ongoing operations on the manufacturing floor. Attend manufacturing morning meeting. Respond to and troubleshoot process issues; evaluate process data including roller bottle and downstream performance. Conduct batch reviews. Provide training to manufacturing personnel. Identify and advance continuous improvement initiatives. Provide inspection support as needed. Provide weekend on-call coverage as needed.
- 10% Process Quality Systems - Support deviation initiation, conduct operator interviews, and provide detailed event descriptions.
- 10% Documentation - Author testing/sampling protocol. Review SOPs and batch records as needed.
- 30% Process Monitoring -A key part of this role will be assisting with continued development of the process monitoring capabilities for roller bottle and downstream operations. The individual will collaborate with key subject matter experts (SMEs) from the Manufacturing Sciences team as well as cross functional groups such as Automation Engineering, Process Development, Manufacturing and the Technical Knowledge Management to assist with the further development of this real time process monitoring system.
Education and Experience Requirements
Essential: BS in Chemical/Biochemical Engineering or Bio/Chemistry with 3 to 5 years or MS with 2 to 3 years of process development/manufacturing experience for the cell culture/purification of recombinant proteins.
Desired: Hands-on experience with large-scale cell culture processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include cell culture, recovery, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes. Experience with troubleshooting / problem solving and risk assessment/ mitigation. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations.
Key Skills, Abilities, and Competencies
Candidate must have knowledge and experience with cell culture/protein purification and GMP manufacturing support, including protein capture and recovery, chromatography purification, filtration, and UF/DF etc. Candidate must have working knowledge of cGMPs and statistical analysis methods. A familiarity with software based statistical analysis programs as well as training in quality improvement techniques, operational excellence tools and1project management is a plus.
As an active participant on multiple cross-functional teams, the candidate must also demonstrate excellent written and verbal communication skills.
Complexity and Problem Solving
Candidate will make process decisions regarding product impact on a regular basis. Candidate will also be required to assess the requirements of processes against the capabilities of existing equipment/facilities interacting with cross-functional team members for review and resolution. Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.
The candidate will:
- Develop solutions to a variety of problems. May refer to established precedents and policies .
- Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrate good judgment in selecting methods and techniques for obtaining solutions. Network with senior internal and external personnel in own area of expertise.
- Have complete understanding and application of principles, concepts, practices, and standards . Full knowledge of industry practices.
- Exert some influence on the overall objectives and long-range goals of the organization .
- Represent organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations
Internal and External Contacts
Incumbent will work closely with Manufacturing, Quality, Engineering, Validation, Process Development, Facility and vendors.
This job posting excludes CO applicants.
LocationsUSA - GA - Social Circle - Hwy 278
Time TypeFull time
Job ID R0035884