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BioSpace
Contributes to the successful implementation of system improvement projects and drives improvements around manufacturing KFA (key focus areas) goals including but not limited to people/safety, quality/regulatory/compliance, customer, financials, and operational excellence. Mentors and guides manufacturing staff on the purification processes, and controls around the process.
Works as part of the Automation Engineering team to partner with Process Engineering, Reliability Engineering, Maintenance and Manufacturing in troubleshooting the automated control processes.
Responsible for administration, maintenance, assessments, evaluations, troubleshooting, diagnostics, optimization and documentation of existing control systems.
Plans, schedules and leads project assignments using various engineering techniques, procedures and criteria with minimal guidance.
How You Will ContributeImplement systems to improve manufacturing KFAs by building a strong partnership with floor leadership. Drives value added results for the business by identifying improvement opportunities from the metrics and implementing them on a timely manner. If metrics do not exist, implement meaningful metrics for the business in a close partnership with floor leadership.
Performs user interventions (UI) to ensure that the manufacturing process maintains a continuous flow. Implements sustainable system to reduce UI occurrence and re-occurrence.
Solves automation system and manufacturing equipment issues that result in production delays, coordinates and contacts support groups for assistance. This support will include DeltaV, EBM, PLC/HMI, BAS, process, equipment, and instrumentation.
Leads the team in day-to-day troubleshooting of control systems and instrumentation, recommends improvements. Implement actions to prevent recurrence - this includes process and equipment issues.
Owns and closes corrective actions related to the automation system; this includes but is not limited to Corrective Action & Preventative Action (CAPA) that are generated due to user interventions and non-conformances/events.
Owns system(s) in the purification process and provides expert feedback for change notices, user interventions, and non-conformance investigations.
Updates Standard Operation and Preventive Maintenance Procedures for the existing equipment and control systems.
Leads the automation scope for large-scale programs and multiple small projects with complex features. Executes projects in accordance with the LA Plant Project Management Methodology guidelines and practices.
Execute and actively participate in ownership of Project Records (PRs) , configuration changes, functional tests, Commissioning Plans, and Qualification Protocols.
Supports PLC/HMI based control systems for various stand-alone equipment such as COP skids, Autoclave and Material Lifts, among others.
Performs financial planning and assists in the analysis to justify project approval.
Reviews, continuously updates and standardizes control systems current technical documentation and drawings: User Requirement Specifications, Functional Specifications, Design Specifications, electrical/control drawings, control network diagrams, system configuration, control components h/w and s/w settings, panel layouts; BOMs, and Spare Parts lists.
Conduct regular audits and revise SOPs/specifications to maintain a rigid connection between control system actions, installation processes, backups, restorations, and manual operations.
Perform system administration activities for control systems.
Develops and formally executes Control System/Equipment Installation, Operation, and Performance Commissioning protocols for modified or new equipment, ensuring successful integration into operations.
Trains Instrumentation and Metrology technicians on control systems functionality, instrumentation configuration, troubleshooting and diagnostic methods and techniques.
Continuously trains Quality Operation, Compliance and Manufacturing personnel on the interaction between manufacturing process and automation.
3+ years of experience in process design, controls engineering and process improvement for automation systems associated with critical, manufacturing and Labs systemsPreferred knowledge of pharmaceutical industry, Rockwell (HMI/PLC), DeltaV and BAS (Desigo).
Important ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Must be able to lift, push, pull and carry up to 25 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Must be able to work in demolition/construction area.
Must be able to work 100% onsite.
More
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.#GMSGQ #ZR1Takeda
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.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/or long-termincentives.
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.
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.
(EEO), Federal Laws and Regulations, Financial Operations, Financial Planning, Functional Testing, Genetics, Hardware Components, Human Machine Interface (HMI), Identify Issues, Instrumentation, Leadership, Lift/Move 25 Pounds, Manufacturing, Manufacturing Automation, Manufacturing Equipment, Manufacturing Systems, Manufacturing/Industrial Processes, Mechanical Engineering, Mentoring, Metrics, Metrology, Multitasking, Patient Care, Preventative Maintenance, Process Engineering, Process Improvement, Professional License, Programmable Logic Controller (PLC), Project Schedule, Regulatory Compliance, Reliability Engineering,
BioSpace
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