Shire Principal Reliability Engineer in Lexington, Massachusetts

Primary Role:

Responsible for improving the reliability of process equipment 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. Drive reliability driven actions that require independent and/or collaborative judgment Project and technical leader and supervises junior staff. May be assigned other duties.

Responsibilities:

  • Leads teams, supervise staff, or performs individually or through cross-functional teams:

  • Identify, develop and present business cases to management for Reliability 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 and Reliability Engineering principles, methodologies and tools.

  • In collaboration with engineering, manufacturing, and maintenance set priorities for improvement projects.

  • Leads Failure Mode Effect Analysis (FMEA).

  • Leads Root Cause Failure Analysis (RCFA).

  • Lead Reliability Centered Maintenance Improvement (RCM) projects in multiple areas.

  • Participate and provide support for audits.

  • Lead the implementation of predictive maintenance across the facility

  • Provide reliability engineering subject matter expertise in the development of design specifications and standards, global engineering and maintenance business practices.

  • Provide Reliability Engineering subject matter expertise to design teams, during the design review and selection of new and modified equipment.

  • May lead or participate in FAT, Commissioning of new and modified equipment

  • May participate in industry forums related to maintenance and reliability

  • May perform other duties as assigned

Key Skills, Abilities, and Competencies:

  • 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 cell culture and purification process equipment

  • Knowledge of chemical and biological safety procedures.

  • Experience with Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable

  • Must have knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, SixSigma / DMAIC, RCFA, 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 and large capital budget items and manage the spending of approved project funds

Education & Experience Requirements:

  • BS in Engineering

  • Advanced degree, PE license, SixSigma or other professional certifications or certificates is a plus

  • 5-8 years of experience.

Other Requirements:

  • 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 buffers that may require respiratory protection.

  • Inside working conditions.

  • 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.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.