Shire Senior Reliability Engineer in Lexington, Massachusetts
Responsible for improving the reliability of process support 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. Lead reliability driven actions that require independent and/or collaborative judgment Support capital projects as needed. Supervision of junior staff as needed. May be assigned other duties.
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.
Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements
CMMS data reliability and integrity improvement.
Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO
Perform functional equivalency assessment of spare parts.
In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment.
Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA).
Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas.
Participate and provide support for audits.
Lead the implementation of predictive maintenance across the facility
Supervise and mentor junior staff
Develop business case for improvements requiring investments and participate in capital planning for assigned area.
Lead, participate, and provide subject matter expertise in the design review and selection of new equipment.
May participate in FAT, Commissioning of new and modified equipment
Manage contractors as needed
Identification of cost/waste/energy reduction projects
May perform other duties as assigned
Key Skills, Abilities, and Competencies:
cGMP experience is desirable
Ability to lead teams and multiple small and medium projects at the same time
Must have knowledge of CMMS and engineering & maintenance business practices / procedures
Must possess knowledge of automation systems
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project.
Must possess strong 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.
Knowledge of chemical and biological safety procedures.
Understanding of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable
Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, SixSigma / DMAIC, FMEA is desirable.
Under supervision, able to organize and present technical and project management plans, schedules and budgets.
Must possess good organizational, verbal and written communication skills;
Membership of relevant professional / technical organization is desirable
Education & Experience Requirements:
B.S. in Engineering
3 - 5 years of relevant engineering 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, buffers that may require respiratory protection.
Pace may be fast and job completion demands may be high.
May be required to visually inspect frequently when completing the following job duty: drawing verifications, field verifications, equipment verification, spare parts verification, 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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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.