- Provides Project Management leadership, expertise, and direction toward the successful execution of multiple, concurrent capital projects, ranging in size up to $5 Million. Examples of some of the types of projects the Engineering PM will lead are equipment installation and replacements, facility renovations and remodeling, and plant shutdowns.
- Delivers lowest cost capital installation by selecting the best value contracting strategies. Utilize industry knowledge and experience to challenge contractor estimates. Influence design constructability and pull appropriate level of engineering support from Discipline Engineering, Process Control, PSTO, QA, and Manufacturing as needed.
- Ensures all projects are executed following a structured methodology going through all phases of the Project Management process. Create estimates and cost forecasts for assigned projects. Lead the bidding process for all third-party requirements, including bid document preparation, contract review, and vendor recommendation. Create and develop the project schedule using tools and methods such as network work diagrams, activity planning matrix, GANTT charts, PERT charts, and WBS.
- Leads in the identification of project ideas, the development of the project's business cases, and the determination of project feasibilities and risk.
- Engages and includes key stakeholders in the PMO office and Division Engineering in the Project Management process. Coordinates with regulatory, QA, and EHS resources to ensure timely filing of all required permits and regulatory paperwork.
- Ensures a safe work environment is maintained through adherence to safety guidelines and policies. Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws.
- Ensures all mandatory training requirements are met, including annual EHS training, GMP refresher training and any applicable training requirements for all employees or contractors.
- Maintains 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.
- Maintains 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 Project Management principals and methodologies.
•Understand design, installation, and commissioning of a variety of types of manufacturing equipment
•Have a thorough knowledge of facilities engineering systems, using blue prints, equipment manuals, specifications, standard operating procedures
•Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements.
•Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
•Must be able to update procedures and modify processes to simply their complexity and improve efficiencies.
•Must have be results oriented with a high level of energy.
•Must have a strong leadership skills.
•Must demonstrate the ability to learn new material quickly and demonstrate high potential for continued professional growth within Engineering.
- Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
- Be Positive
- Be Accountable
- Be Results Oriented
Be An Excellent Manager of Self and Others Education and/or Experience
•B.S in an Engineering field is required.
•PMP Certification is also desired
•Must have 5-10 years of overall Engineering experience and at least 3 years of experience leading engineering projects for an FDA regulated facility in a cGMP environment. Working Environment
•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. Physical Demand
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.
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