- Operate Clean-in-Place (CIP) and Steam-in-Place systems.
- Assemble valve assemblies and filter carts
- Operate general production equipment (such as autoclave, COP washer, etc.)
- Execute Electronic Batch Management (EBM) program to document all activities
- Complete all relevant paperwork following GDP/GMP guidelines.
- Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.
- Perform sampling using aseptic techniques
- Participate on Continuous Improvement Teams
- Receive and distribute supplies into production areas as necessary.
- Train and mentor other team members
- Revise and review pertinent documentation as appropriate
- Assist in troubleshooting process problems and responding to alarms
- May perform other duties as assigned
Education and/or Experience:
- Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.
- Ability to gain in depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish).
- Must have customer services attitude and willingness to assist with any maintenance related problem.
- Must be able to read, write and converse in English.
- Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have 20/20 corrected vision. This position requires the ability to pass eye exam including depth perception and color blindness testing. Hiring is dependent on the ability to pass visual exam and visual inspection qualification.
- Experience in a regulated production environment desirable:
- Bachelor s degree or
- AA or equivalent plus at least 2 year of experience or
- High School diploma or GED with at least 4 years of experience.
- Must have working knowledge of scientific principles
- Scientific or technical degree preferred.
Physical Demands/ Work Conditions:
- Must be able to lift, push, pull and carry up to 50 lbs.
- 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 work environment.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- Will work around chemicals such as alcohol that may require respiratory protection.
- May be required to work or be assigned to a different shift as needed.
- Must be able to work weekends or overtime as required.
- Inside working conditions.
- Some clean room and cool/hot storage conditions.
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.