Essential Duties & Responsibilities
Under supervision or as directed:
1. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.
2. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment.
3. Perform data analysis of corrective work orders in CMMS to identify trends and area focus for improvements
4. Perform functional equivalency assessment of spare parts.
5. In collaboration with engineering, manufacturing, and maintenance personnel perform or support troubleshooting of equipment.
6. Conducts or participates in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
7. Execute Reliability Centered Maintenance (RCM) or other improvement projects in assigned area.
8. Participate and provide support for audits as needed.
9. Support the implementation of predictive maintenance across the facility.
10. May assists in the preparation of and/or participation in technical reviews of equipment design projects.
11. May participate in FAT and commissioning of new or modified equipment.
12. Identify cost/waste/energy reduction opportunities.
13. May be assigned change control, Quality CAPA and Safety CAPA tasks.
14. Report project and operational metrics.
15. May perform other duties as assigned.
Familiarity with cGMPs is a plus
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project.
Must possess knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
Must be organized and detail focused.
Familiarity with Biotechnology manufacturing operations such as aseptic filling, packaging and their support systems such as CIP, SIP, HVAC, plant and clean utilities, is a plus.
Familiarity with project management principles is a plus.
Education and/or Experience
B.S. in Engineering.
1 - 3 years of experience.
May be required to travel for business reasons, e.g. training and meetings.
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.
The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
May work in a cold, wet environment.
May be exposed to sunlight and heat.
May be exposed to dust, gases, and fumes.
Possible exposure to cool/hot storage conditions.
May be around moving equipment and machinery.
May be working in a loud area that requires hearing protection and other protective equipment to be worn.
May work around chemicals such as alcohol, acids, and bases that may require respiratory protection.
Inside working conditions.
May require immunization before performing work within the manufacturing area.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
May be required to lift up to 25 pounds
May be required to push up to 25 pounds
May be required to pull up to 25 pounds
May be required to visually inspect frequently when completing the following job duty: start-up, troubleshooting, inspection and commissioning of equipment.
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.