Are you looking for a patient-focused, innovation-driven 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 II 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 II working on the Biologics Manufacturing team, you will be empowered to use your GMP experience to improve process operations, and a typical day will include:
- Performing and documenting cGMP activities to support upstream and downstream production areas and operations . This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
- Training less experienced manufacturing associates.
- Supporting deviation investigations and may participates in cross functional projects teams, may support technical transfers with relevant teams/individuals and is involved in other assignments as directed.
Qualifications: REQUIRED QUALIFICATIONS:
- Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system.
- Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks.
- Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s
- Performs the weighing, dispensing of raw materials for media and buffers
- Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product
- Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders , filter integrity testers etc.
- Dispensing, labeling, transfer/staging of raw materials and parts
- Assembly/disassembly, cleaning and sterilization of components, parts and equipment
- Maintaining equipment, area and cleaning logbooks
- Cleaning sanitizing production rooms and equipment,
- Stocking production and cleaning supplies
- Author/ review/improve SOP’s, batch records, protocols and technical reports
- Actively participates in training activities, managing their individual training plan.
- Utilizes Manufacturing knowledge to train others, improve process operations and affect positive change and demonstrates ability to troubleshoot basic mechanical operations.
- Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing areas.
- Advanced knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
- Experience with cGMP Biotech or Pharmaceutical operations
- cGMP: Understands cGMP requirements and follows those requirements, including requirements for good documentation practices.
- Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
- Possess excellent written and oral communication skills.
- Possesses advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
- Possesses advanced understanding of the scientific theory of biologics manufacturing:
- understands biotechnology processing - purpose of major unit operations and microbial control concepts
- Actively pursues learning of required skills, new skills, and new equipment
- Understand routine procedures upon which they have been trained.
- Possesses advanced equipment understanding, including understanding equipment function and application.
- Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing area
- Ability to train less experienced or new manufacturing associates.
- Proficient in MS Office and related PC skills
- Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 1-2 years relevant experience, or Associate’s Degree in a scientific or engineering discipline with a minimum of 2-4 years related experience, or High School Diploma with a minimum of 2-6 years relevant experience.
WHAT TAKEDA CAN OFFER YOU:
- Is required to stand, operate manufacturing equipment, computer equipment; and is required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection.
- May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
- May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
- May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
- May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
- May be required to drive rarely to attend offsite meetings and/or training.
- May be required to use hearing occasionally when listening for production and equipment alarms.
- Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
- May be required to perform visual inspection of production equipment, materials, and activities.
- May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
To further support and inspire our employees, our benefits include:
- Company-paid volunteer days
- Company match of charitable contributions
- 401(k) with company match, and annual retirement contribution plan
- Adoption assistance and tuition reimbursement program
Empowering Our People to Shine www.takedajobs.com Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx No Phone Calls or Recruiters Please.