Essential Duties & Responsibilities
- Oversees, and provides system ownership and troubleshooting of site 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 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.
- Provides engineering support for HVAC and utilities equipment/Systems.
- Prepares complex designs, standards, studies and analysis.
- Provides a detailed design review of internal and external technical documents.
- Reviews and technically approves maintenance reports, forms, and records.
- Interprets and/or modifies available procedures and guidelines for application to existing problems and processes.
- Generate and complete critical systems change control.
- Conduct and lead failure Root Cause Analysis (RCA) and generate appropriate CAPA, change control, reports.
- Prepares cost estimates and project evaluations without direct supervision.
- Plans and develops project budgets with appropriate/required documentation.
- Ensures compliance with codes, standards, and design, operation, and maintenance requirements.
- Identifies potential areas of weakness with assigned work, and initiates corrective action.
- Documents and shares work with others to strengthen the depth and breadth of skills within team.
- Ensures that problem solutions are tailored to the Shire business environment.
- Supports emergency response work as requested including immediate and extended restoration efforts driven by weather and other system failures.
- Must be familiar with plant and divisional SOPs as related to positional and department responsibilities.
- Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws.
- Ensures personal Training Plan execution and compliance. Attends required training and meetings.
- Interact with and oversee contractor/vendor work
- Provide training for staff, clients and project personnel.
- Provide regulatory and partner audit support.
- May participate in On-Call rotations for after-hours facility and manufacturing support and may work outside of established shift hours upon short notice.
- May lead or coordinate the work of junior engineers, engineering assistants, technicians, and others who assist on in work/project activities (This includes contractor/consultants.)
- May perform other duties as assigned.
- Basic level of knowledge of cGMP manufacturing.
- Knowledge of basic industry safety procedures related to job description.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment. Good customer service skills.
- Knowledge of chemical and biological safety processes/procedures.
- Must be able to read, write, and converse in English.
- Good computer skills, knowledge of Microsoft Outlook, Word, PowerPoint, Excel, and Project.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, training, and self-service applications.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Good Mechanical Writing skills for SOP, flow chart, job aid, Job/work plan development.
- Possesses very strong verbal and written communication skills and Good Documentation Practices (cGDPs) knowledge
- Must have the following personal attributes:Self-motivated, integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Be aware of hazardous chemicals and their disposal, OSHA and FDA requirements.
- Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Education and/or Experience
- Be Positive
- Be Accountable
- Be Results Oriented
- Be An Excellent Manager of Self and Others
Bachelor of Science degree in Mechanical or Civil Engineering or related field. 6-8 years related experience in planning, design, specification preparation, maintenance, project cost estimating and scheduling. Demonstrated organization, documentation, prioritization, and project management skills. Good communication skills and the ability to perform effectively in multi-disciplinary teams. Working Environment
- Must be able to work more than 8 hours a day or 40 hours a workweek, as required.
- 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.
- Must be able to wear personal protective equipment that may be tight to the body and limit motion.
- May work in cold, wet environments or hot, humid environments, inside or outside the facility.
- May be exposed to sunlight and heat.
- May be exposed to dust, gases, and fumes.
- May be around moving equipment and machinery.
- May be working in a loud area that requires hearing protection and protective equipment to be worn.
- May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
- Will work around chemicals such as paint, flooring materials, refrigerants, alcohol, acids, buffers, etc. that may require respiratory protection.
- May be required to travel for business reasons.
- Pace may be fast and job completion demands high.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.