Executive / senior industry position
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A experienced professional with 15+ years of experience leading capital project teams and site production teams focused on Aseptic Processing in the areas of Filling Line Technologies, Lyophilization Technologies, Automated Loading and Unloading Technologies and other associated sterile operations.. Activities will be to oversee and manage a team of process, validation, and construction engineers and coordination with the US/ROW and China Project Management Offices (PMO) for the design, construction, commissioning and qualification of large aseptic capital projects across the WuXi network. Activities will include driving US & ROW and China based A/E firms on Concept, Basic and Detailed Design Phases, assisting the formation and training of the local Project Teams. Provide Global Engineering SME Leadership to develop the conceptual, basic, and detailed designs and construction/validation of major aseptic capital projects for the WuXi Global network.
- Provide Subject Matter Expert Leadership in the areas of Aseptic Processing which will include filling line technology, lyophilization technologies, automatic loading and Unloading technologies and other associated aseptic processing technologies.
- Manage/Mentor and develop a Vaccines Engineering Team focused on vaccines manufacturing across the WuXi network. Work closely with other Global Engineering teams to provide Project Management and Aseptic SME support across all drug product related global facilities at WuXi.
- Lead and attend all key project related meetings for assigned US/ROW projects and assist on China projects as required.
- Work to further develop Process Engineering and Engineering Project Standards/Guidelines in the aseptic processing area. Ensure these standards are applied to the design, construction, commissioning and qualification of global aseptic projects across the WuXi network.
- Work closely with the various aseptic technology vendors in the specification/design/FAT/Site Installation and Qualification of these integrated systems.
- Develop WuXi standards in the area of Automated Visual Inspection systems working closely with key vendors in this specialized area.
- Ensure project scope is well defined, and manage overall cost and schedules against the defined scope in the areas of aseptic processing across these WuXi facilities.
- Review and approve design documentation including engineering calculations, specification and drawings for process mass and energy balances, HVAC, process piping, clean and plant utilities piping and normal power/emergency power and UPS systems.
- Engage with all aseptic process equipment vendors with an emphasis towards single use technology for biologics manufacturing and packaged process equipment.
- Manage facility construction activities, equipment/system start up and commissioning activities across numerous projects across the WuXi network.
- Review and approve commissioning and qualification protocols.
- Provide qualification and troubleshooting support for process equipment and utility systems.
- Ensures that the design, construction, commissioning and validation of the WuXi Process Development and Commercial facilities comply with appropriate regulatory requirement and construction codes
- Ensures Senior Management is well informed on progress of the Global GMP Facilities construction
- Assist on other US/ROW and China Global Engineering activities as required.
- 15+ years experience in leading process teams on the delivery of large scale aseptic processing projects and overall project delivery.
- Excellent communications skills on technical process, engineering and project management topics
- Fluent in written and verbal English communication
Experience / Education
- Bachelors’ degree with a major in Chemical or Biological Engineering or other science related field or equivalent experience, MBA Preferred
- PMP Project Management Certification Preferred
Knowledge / Skills / Abilities:
- Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
- Ability to evaluate technical data and write technical documents.
- Ability to use judgment as dictated by complexity of situation.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Ability to understand and follow verbal or demonstrated instructions.
- Ability to express or exchange ideas by means of the spoken word.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook and other systems)
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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Executive / senior industry position