Manufacturing Lead Operator

Company: Takeda Pharmaceutical
Location: San Gabriel
Posted on: August 4, 2022

Job Description:

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Job Description

Shift 2 (Swing): This position reports to Swing (2) shift. This shift schedule is Monday-Friday from 2:00 PM to 10:00 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

About the role:

The Manufacturing Lead Operator supports all our processes in production in B8 Purification which may include small, mid or large-scale manufacturing, while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the direction of the supervisor, they must help establish daily shift priorities, and then communicate and delegate tasks to safely accomplish those priorities with regards to Safety, Quality, and Production decisions. You will apply their subject matter expertise and their understanding of the capabilities and performance of their team members to quickly assess important issues. You will escalate all relevant information and be prepared to recommend appropriate actions. You will communicate all important information to their respective teams and shift-to-shift updates through all applicable communication tools and at shift handoffs. In addition to being accountable in production processes, you may help in other areas. You will participate in both departmental projects and quality working teams. You will be a delegate to the supervisor and may conduct departmental activities in their absence. You understand the regulations and may make recommendations according to their interpretations. They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable. You must display the appropriate conduct, compliance, cleanliness, and culture while promoting Takeda's focus on Patient, Trust, Reputation, and Business.

How you will contribute:

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and programs.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform hands-on execution of manual and automated manufacturing operations. Equipment may include: Centrifuges, Filter Presses, Ultrafiltration, Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities.
• Train and maintain standards to be proficient in multiple products and support multiple areas within the manufacturing suites.
• Interface and Navigate through the DeltaV, Programmable Logic Controller (PLC), and Electronic Batch Management (EBM) systems to respond to process events, changes, and tasks
• Respond to alarms and escalate the issue to management and the appropriate support groups
• Coordinate manufacturing process related issues with Quality Operations before intervening in the system
• May receive and distribute supplies into the production area.
• May remove hazardous waste
• Be the primary manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor. Main interface with other departments including maintenance, metrology, engineering and validation.
• Assist supervisor in organizing, scheduling, and directing other team members.
• May be a delegate to the supervisor in their absence.
• Participate in the training and mentoring of team members on the manufacturing floor.
• Write, revise, and review manufacturing related documents as appropriate.
• Participate in Safety and Continuous Improvement Teams and may serve in a leadership role.
• Initiate and/or coordinate other process improvement projects.
• Drive performance of team members by promoting a positive work environment emphasizing Patient, Trust, Reputation, and Business.
• Previous experience managing effective teams.
• Experience exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.
• In-depth process knowledge of related manufacturing techniques and specialties.
• Familiarity with pharmaceutical production equipment including centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
• Knowledge of basic chemical and biological safety procedures.
• Must have good computer skills including knowledge of Microsoft Office applications. Experience with applications such as LIMS and JD Edwards preferred.
  
  What you bring to Takeda:
  • Requires high school diploma and a minimum of 6 years related experience, or Bachelor with minimum of 4 years related experience. College degree in Science or Engineering discipline strongly preferred.
  • Must be able to lift, push, pull and carry up to 50 lbs.
  • Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
  • Must be able to climb ladders and stairs while wearing special gowning.
  • May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
  • 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 around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
  • Will work in a cold, wet environment.
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work overtime as required. (only for non-exempt positions)
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.
    
    What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • Health & Wellness programs including onsite flu shots and health screenings
    • Generous time off for vacation and the option to purchase additional vacation days
    • Community Outreach Programs and company match of charitable contributions
    • Family Planning Support
    • Professional training and development opportunities
    • Tuition reimbursement
      
      More about us:
      
      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.
      
      Empowering our people to shine:
      
      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.
      
      Location and Salary Information: This post excludes CO applicants
      
      
      
      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 - CA - Los Angeles
      
      Worker Type
      
      Employee
      
      Worker Sub-Type
      
      Regular
      
      Time Type
      
      Full time

Keywords: Takeda Pharmaceutical, San Gabriel , Manufacturing Lead Operator, Other , San Gabriel, California