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Job Description

You will report to Weekend Night (E) shift. This shift schedule is Saturday and Sunday 10:00 PM to 10:00 AM, plus a third day during the week. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and support operations on an alternate shift.

About the role:

The Manufacturing Lead Operator supports all current and future 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. They are expected to help with regards to Safety, Quality, and Production decisions. You can apply subject matter expertise and understanding of the capabilities and performance of team members to quickly assess important issues. You will report to the supervisor of manufacturing.

How you will contribute:

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and plans.
• 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

What you bring to Takeda:

• In-depth process knowledge of related manufacturing techniques and specialties.
• Correct GDP type errors in the electronic systems (DeltaV, EBM, PLC, etc.)
• Trend data in DeltaV and EBM systems for investigations and process deviations
• Proficient in DeltaV and EBM to a level that aligns with the your responsibilities and standard operating procedure (SOP) guidance
• Familiarity with pharmaceutical production equipment including centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
• 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.
• Can 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.
• May work in a cold and/or wet 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.
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required.
• 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.

Base Salary Range: $ Range Min to $ Range Mid. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

#GMSGQ #ZR1

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.

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