Responsible for improving the uptime performance of filling and packing equipment by applying LEAN manufacturing principles. Apply problem solving methodologies to support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure production performance to demonstrate successful improvements. Drive improvement actions that require independent and/or collaborative judgement. Project and technical leader for junior staff.
Essential Duties & Responsibilities
- Leads, sets direction individually or through cross-functional team:
- Identify, develop and present business cases to management for equipment uptime performance improvement projects and participate in capital planning in assigned area(s).
- Lead or participate in large, site, or cross-functional reliability improvement projects
- Participate in engineering & maintenance business process improvement initiatives.
- Supervise technical teams and contractors
- Supervise and mentor junior staff in Process Improvement principles, methodologies and tools.
- In collaboration with engineering, manufacturing, and maintenance; set priorities for improvement projects.
- Leads DMAIC improvement projects
- Leads Failure Mode Effect Analysis (FMEA)
- Apply Lean / Six Sigma tools and methodology
- Participate and provide support for audits.
- Lead the implementation of predictive maintenance across the facility
- May lead or participate in FAT, Commissioning of new and modified equipment
- Ability to solve routine engineering tasks and manage projects with minimal assistance
- Ability to work seamlessly and effectively with employees of varying backgrounds, education, and experience
- May perform other duties as assigned
- cGMP experience required
- Ability to lead teams and medium size projects
- Must have proficient knowledge of CMMS and engineering & maintenance business practices / procedures
- Must proficient possess knowledge of laboratory and pharmaceutical production and support equipment, including utilities and critical systems (aseptic filling, packaging, CIP, SIP, HVAC, plant and clean utilities)
- Knowledge of chemical and biological safety procedures.
- Must have knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, SixSigma / DMAIC, FMEA.
- Must be able to organize and present technical and project management plans and schedules without assistance.
- Must have excellent organizational, verbal and written communication skills;
- Communicate effectively with cross-functional teams, global teams and management.
- Proficient user of computers
- Estimate medium capital budget items and manage the spending of approved project funds
- 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
- BS in Engineering
- Advanced degree, PE license, SixSigma or other professional certifications or certificates is a plus
- 5-8 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, 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.
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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.