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Shire Sr Utilities Engineer II in Thousand Oaks, California
Under minimal to no supervision, the Sr Critical Utilities Engineer will be a skilled Engineer with responsibilities encompassing oversight of one or more of the following systems: Electrical distribution, HVAC, Water, Steam, Gas and Waste systems used in manufacturing plants, utility plants, analytical labs, and office areas. They will be responsible for performing or managing advanced installation, troubleshooting, repair, testing, and documentation of activities as they pertain to the described systems. They will be involved and potentially lead preconstruction activities such as project management, design, engineering and permitting. All work must be completed in a safe (in accordance to HRA, JHA, etc.), timely manner according to planning and predefined schedules with minimal impact to production while complying with GMP, SOP, State, Federal and company regulations.
Essential Duties & Responsibilities
•Oversees, and provides system ownership and troubleshooting of one of more of following site systems: Electrical distribution, HVAC, Water, Steam, Gas and Waste Water systems including, but not limited to: Environmental control units, Chilled Water, WFI, RO, Plant Steam, Clean Steam, LN2, O2, CO2, N2, AIR, Waste Systems.
•Responsible for all aspects of the assigned equipment used in the production, control and distribution the various utilities, including, but not limited to: AHUs, Exhaust Fans, HEPA Filtration Equipment, Cooling Towers, Chillers, Vapor Compression Units, RO Units, DI Units, Clean Steam Generators, Boilers, Distribution Tanks, Air Compressors, Pumps, emergency generators, UPS, ATS/switch gear.
•Provides engineering support for systems and equipment above.
•Prepares complex designs, standards, studies and analysis.
•Provides a detailed design review of internal and external technical documents.
•Manage Sustainability and Energy management programs including financial analysis and gains
•Understands the CQV process and is able to develop and execute validation activities.
•Identify opportunities to utilize the Plant’s critical systems in a more efficient manner to improve reliability and reduce operating costs.
•Conduct and lead failure Root Cause Analysis (RCA) and generate appropriate CAPA, change control, reports.
•Submit capital requests as needed to support equipment replacement, upgrades, and other improvements. Partner with Project Engineering and Project Managers to ensure the smooth transition of Projects into day-to-day operations.
•Partner with Utility Management, Reliability Engineering and Capital projects to conduct life cycle analysis of assigned system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.
•Partner with reliability engineering to ensure FMEAs are established for all assigned critical systems and drive resolution for any recommendations. Assist and may own as needed, root cause analysis.
•Ensure all mandatory training requirements are met, including annual EHS training, GMP training and any applicable training requirements for all employees.
•Supports emergency response work as requested including immediate and extended restoration efforts driven by weather and other system failures.
•Maintain an on-going two-way performance dialogue with manager and meet timelines for completing all mid and year-end reviews and development plans for self and direct reports.
•Maintain a positive, professional and customer oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to the supervisor, manager, or human resources.
•May perform other duties as assigned.
•Must be proficient with respect to the operation and maintenance of various utility systems including, but not limited to: Electrical distribution, HVAC, WFI, RO, clean steam, plant steam, compressed air, nitrogen, boilers, lyophilizers and wastewater treatment plants.
•Understand the design, installation, and maintenance of Electrical Services and equipment that support a complex manufacturing plant.
•Have a thorough knowledge of utility equipment, using blue prints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgment when taking corrective actions during equipment malfunction.
•Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements.
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
• Must have very strong verbal and written communication skills, presentation skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
•Good computer skills including typing and knowledge of Microsoft Word, PowerPoint, Visio and Excel
•Must be able to update procedures and modify processes to simply their complexity and improve efficiencies.
•Must be able to present project overviews and other departmental presentations without assistance.
•Must demonstrate the ability to learn new material quickly and demonstrate high potential for continued professional growth within Engineering.
Education and/or experience
•B.S in an Engineering or related field is preferred.
•8-12 years of experience working in an FDA regulated facility in a cGMP environment is preferred.
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 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.
•May be exposed to sunlight and heat, may work in a cold and wet work environment.
•May be exposed to dust, gases, and fumes.
•May be around moving equipment and machinery.
•May climb up and into large processing tanks for cleaning or inspection.
•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.
•May be required to work or be assigned to a different shift as needed.
•Must be able to work more than 8 hours a day or 40 hours a workweek as required.
•This position requires shift, weekend and holiday work.
•May be required to work in a confined area as defined by the Environmental, Health, & Safety office
•Possible exposure to cool/hot storage conditions.
•Will have interaction with other people.
•Pace may be fast and job completion demands may be high.
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/OFCCPEEOSupplementFinalJRFQA508c.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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.