Manufacturing Associate I - Day Shift

Takeda; Brooklyn Park (MN); On-site; USD 41,000 - 65,000; Full time

Job summary

Takeda in Brooklyn Park, MN is seeking a Manufacturing Associate I to perform daily manufacturing operations in a cGMP environment, operating bioreactors, filtration units, and chromatography systems while following SOPs.

You will handle materials, assemble and clean equipment, maintain logs, complete batch records, and enter data in SAP and LIMS, with a rotating day schedule from 5:45 AM to 6:15 PM.

Qualifications

• High school diploma or GED required; GMP experience ideal.
• Associates degree or higher in science preferred.
• Understanding of cGMP and GDP is advantageous.
• Familiarity with QC/Regulatory/QA functions beneficial.
• Experience with lab equipment helpful.

Responsibilities

• Dispense, label, and transfer raw materials and parts.
• Assemble/disassemble, clean, and sterilize components and equipment.
• Maintain equipment, area, and cleaning logs.
• Operate biologics production equipment under supervision.
• Document cGMP data in batch records and logs.
• Manage process parameters in batch records and control systems.
• Complete batch records and validation protocols.
• Review equipment use logs and perform SAP transactions.
• Enter data into LIMS and perform cleaning/sanitizing.

Skills

GMP environment

cGMP knowledge

GDP knowledge

Lab equipment experience

MS Office

Math calculations

WBT training

Documentation

Safety compliance

Education

High school diploma or GED

Associates degree or higher in science

Biotech/pharma operations knowledge

QC/Regulatory/QA knowledge

Tools

SAP

LIMS

Job description

About the role

As a Manufacturing Associate I, you will perform daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will complete validation protocols. You will report to the Manufacturing Supervisor.

This is a day shift role with a rotating schedule. The working hours are from 5:45 AM to 6:15 PM.

How you will contribute

• Perform dispensing, labeling, and transferring/staging of raw materials and parts.
• Will assemble/disassemble, clean, and sterilize components, parts, and equipment.
• Maintain equipment, area, and cleaning logbooks.
• With general management or guidance will assemble and operate biologics production equipment, such a bioreactors, filtration units, chromatography systems and fixed/portable vessels.
• Perform basic trouble shooting.
• Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
• With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
• You will complete batch records and validation protocols under management/direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Perform data entry into LIMS.
• Perform cleaning/sanitizing production equipment.

What you bring to Takeda

• High school diploma or GED.
• Experience in GMP environment would be ideal.
• Associates degree or higher in a scientific discipline would be ideal.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) would be ideal.
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management would be ideal.
• Prior experience with lab equipment would be ideal.
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Can perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web-based Training (WBT).
• Familiar or experience with cGMP within Biotech or Pharmaceutical operations would be ideal.

Important Considerations

• Required to wear personal protective equipment (PPE) and other clean room garments. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
• Carry weight, Pushing, Pulling Lifting - Required to carry, lift, push, and pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and materials.
• Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.
• Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations.
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations.
• Move Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time.
• Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time.
• Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time.
• Must have the ability to work assigned shift (day or night).
• Required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• On rare occasions, travel may be required to offsite meetings or training event.

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.

#GMSGQ #ZR1 #LI-MA1

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:

Brooklyn Park, MN

U.S. Hourly Wage Range:

$19.81 - $31.10

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits please click here.

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No