Under the direction of the Manager for Reliability Engineering, contribute to the reliability, design, development and enhancement of manufacturing and support equipment.
Responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Support capital projects as needed. May be assigned other duties.
Essential Duties and Responsibilities:
- Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment.
- Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment
- Perform data analysis of corrective work orders in CMMS to identify trends and area focus for improvements
- Perform functional equivalency assessment of spare parts.
- In collaboration with engineering, manufacturing, and maintenance personnel perform or support troubleshooting of equipment.
- Conducts or participates in Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
- Execute Reliability Centered Maintenance (RCM) improvement projects in assigned area.
- Participate and provide support for audits.
- Support the implementation of predictive maintenance across the facility
- May assists in the preparation of and/or participation in technical reviews of equipment design projects.
- May participate in FAT and commissioning of new or modified equipment
- Identify cost/waste/energy reduction opportunities
- May be assigned change control, Quality CAPA and Safety CAPA tasks
- Report project and operational metrics
- 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: 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 Cell Culture, purification, 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.
- Passion for Improving Lives:Must be able to put our patients at the center of everything we do.
- Quest for Innovation: Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
- Inspired Teams environment:Must be able to thrive in diverse high performing teams.
- Engaged with the World around Us: Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Education and/or experience:
- B.S. in Engineering and 1-3 year or MS in Engineering and 0-2 years related experience. The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams
- Demonstrated success in delivering results in several technical challenges.
- The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams.
- 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 manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required (APPLICABLE TO SNE only).
- May be required to work in a confined area.
- 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.
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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.