Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manufacturing Associate I in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Associate working on the Manufacturing team, you will be empowered to use your knowledge of current Good Manufacturing Practices and develop expertise with biologics manufacturing processes, and a typical day will include:
- Perform and document daily manufacturing operations according to SOP s in a cGMP environment
- Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
- Execute validation protocols
- Create or revise cGMP documents
- With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
- Perform basic trouble shooting
- Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
- Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
- Executes batch records and validation protocols under supervision/direction of others
- Author and review equipment use logs
- Performs inventory transactions in SAP
- Performs data entry into LIMS
- Accountable for completing assigned trainings within required timeline and actively participate in training activities.
- Stock production and cleaning supplies
- Perform cleaning/sanitizing production rooms and equipment
- Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Preferred combination of education and experience:
- Bachelor s degree in Science or Engineering; or
- Associate s degree in science-related area and 1 or more years of relevant experience; or
- High school diploma or GED and 3 or more years of relevant experience.
- Experience in a regulated environment preferred
Knowledge, competencies and skills:
- Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
- Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
- Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
- Prior experience with lab equipment a plus
- Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
- Must have excellent written and oral communication skills
- Must be team and detail-oriented and able to work in a fast-paced environment.
- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
- Must be able to read and understand English
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily
- Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or 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
- Moving 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)
- Will be 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
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.
Brooklyn Park, MN