Shire Engineering Project Manager in Thousand Oaks, California
The Engineering Project Manager is recognize as a key role within the Thousand oaks Engineering Department. It provides the Project Management leadership, expertise, and direction toward the successful execution of multiple, concurrent capital projects, ranging in size up to $10 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. Accountable for the overall project performance including integration of project activities, project resources, financial achievement and is a liaison for senior management and other internal and external stakeholders. He/she will provide input into the key strategic business portfolio processes to ensure funding for business objectives. Accountable for the proper execution of all main phases of the project, since definition, conceptualization, business case, up to full execution, start up, commissioning, qualification and project close out.
Essential Duties & Responsibilities
Provides Project Management leadership, expertise, and direction toward the successful execution of multiple, concurrent capital projects, ranging in size up to $10 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.
Accountable for overall project health, and implementation activities.
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.
Provides technical support in required phases of product manufacturing.
Anticipates potential conflict situations, identifies and acts on proactive solutions.
May perform other duties as assigned.
•Must be proficient with respect to Project Management principles 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 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 5 years of experience leading engineering projects for an FDA regulated facility in a cGMP 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.
Notice to Employment / Recruitment Agents:
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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.
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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.