This shift schedule is Sunday to Wednesday 6:00 AM to 4:30 PM. Due to business need, you may be required to work overtime and/or support operations on an alternate shift.
The Manufacturing Associate II is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. This position is expected to fully participate in both departmental projects and any quality working teams which may be applicable. This positions initiates new documents for procedures which are simple in nature and may also make minor revisions to existing documents. The incumbent can troubleshoot simple existing procedures. This position may demonstrate procedures as a part of a training session and may schedule department or process activities which could involve co-workers. All of the specific requirements presented in this job description are applicable to the functional area in which it resides.
Essential Duties & Responsibilities
- Support Cell Culture/Purification operations for the production of a bulk drug substance product.
- Prepare media and buffer solution.
- Clean, Set up, operate, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines.
- Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
- Monitor and record critical process parameters.
- Complete relevant paperwork following GDP/GMP guidelines.
- Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
- Manually clean portable equipment and small parts.
- Perform sampling using aseptic techniques.
- Participate on Continuous Improvement Teams.
- Receive and distribute supplies into production area as necessary.
- May perform other duties as assigned.
- Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations.
- Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
- Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
- Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
- Receive and distribute supplies into the manufacturing areas.
- May perform other duties as assigned.
- Must be able to perform the qualifications of a Manufacturing Associate I.
- Technical Skills Comfortable with set-up and operations, daily maintenance, and break down of simple/routine equipment. Qualified to perform CIP, SIP autoclave, small parts preparation. Able to identify processing gaps and assist with implementation of new technologies. Has access to JDE and understand how to create facility Work Orders
- Troubleshooting Proficient at troubleshooting minor to moderate problems. Understands when and to whom to elevate.
- Theoretical Knowledge - Understands the scientific and technical background associated with areas they are performing.
- Written Communication - Able to draft simple to moderate DCRs and complete minor NCR investigations.
- Interpersonal Communication - Communicates professionally within and outside of the department.
- Presentation Skills Able to present clear-cut concepts to local group.
- Sphere of Influence Able to influence within the operational group.
- Leadership Able to lead group through a major process step.
- Logistics - Understands systems for purchasing routine items. Able to procure items and supplies.
- Planning Consistently understands and provides feedback for operations occurring within the current work week.
- Processing Capabilities - Takes the lead during processing steps. Prepares the shift for upcoming processes.
- Project Performance - Able to lead a department team or moderate project with oversight. Consistently works as a project team member on Kiazen and other improvement initiatives.
- Training - Can successfully train newer team members on routine processes.
- Continuous Improvement - Actively performs as equipment and room owner. Applies 5S and TPM as required to improve area.
- The position requires shift, weekend, and holiday work. Overtime may be required at times.
- Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).
- Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.
- Understand ergonomic relationship between people, equipment and working environment.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Must have the ability to navigate electronic mail systems and intranet for communication purposes.
Education and/or Experience
Requires Bachelor s degree with a minimum of 1 year of manufacturing experience or AA degree with minimum of 3 years of related work experience or a high school diploma with a minimum of 5 years of related work experience. Scientific degree preferred.
The aforementioned requirements are preferred for internal candidates. They must demonstrate the proficiencies/qualifications in order to qualify for the position.
- Must be able to work in controlled or clean room 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 these work environments.
- Will have interaction with other people.
- Pace may be fast and job completion demands may be high.
- This position requires shift, weekend and holiday work.
- Overtime may be required at times.
- May be required to work or be assigned to a different shift as needed.
- The overall physical exertion of this position requires medium to heavy work.
- May be required to sit between 1-2 hours in all Manufacturing areas.
- May be required to walk between 3-4 hours in Bulk and over 4 hours in the F/F and Suite A areas.
- May be required to stand for 3-4 hours in Bulk and Suite A and over 4 hours in F/F.
- May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A and over 4 hours in the F/F areas.
- May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A and F/F.
- May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas.
- May be required to reach above/below the shoulder between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May be required to kneel up to 1 hour in all Manufacturing areas.
- May be required to twist at the neck up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F area.
- May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the F/F and Suite A areas.
- May be required to lift up to 50lbs in the F/F area, up to 75lbs in Bulk and over 75lbs in the Suite A area. Lifts per shift are up to 14 times in Bulk and Suite A and up to 100 times in the F/F area.
- May be required to carry up to 25lbs in Bulk and Suite A and up to 50lbs in the F/F areas. Carry distance of up to 30ft in Bulk and Suite A and up to 6 feet in the F/F areas. Carries per shift are up to 6 times in Bulk, up to 14 times in Suite A and up to 100 times in the F/F areas.
- Requires repetitive use of both right and left hands and arms up to 3-4 hours in all Manufacturing areas.
- May require simple grasping up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May require power grasping up to 1 hour in Bulk and Suite A and over 4 hours in the F/F areas.
- May require fine manipulation up to 1 hour Bulk and Suite A and between 1-2 hours in the F/F areas.
- May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A and the F/F areas.
- May be required to gown frequently and balance when gowning into clean areas.
- Will not be required to drive cars, trucks, forklifts or other equipment.
- May be required to work around moving equipment and machinery.
- Will not be required to walk on uneven ground.
- May be exposed to noise above 85 dBA in Bulk and Suite A. This may require hearing protection and other protective equipment to be worn.
- May work and have exposure to hot, cold, wet environment/conditions in all Manufacturing areas.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
- May be required to work at heights above floor level.
- Will not be required to operate foot controls or repetitive foot movement.
- May require the use of special visual or auditory protective equipment in Bulk and F/F areas.
- May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste in the F/F areas.
- May be required to drive to travel to other facilities, training sites, and off site meetings.
- May be required to work in confined areas.
- Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite in the F/F area.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.