In this role you will manage the design, specification, and installation of new and renovated biopharmaceutical process equipment. Provide engineering support and problem solving for existing equipment and manufacturing processes. Provide technical expertise to engineering, automation, and related departments.
As a Staff Project Manager - Engineering a typical day might include, but is not limited to, the following:
- Manage the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP process equipment, piping, and controls.
- Responsible for the identification and mitigation of risks to ensure business continuity and protect the company from loss.
- Prepare, present, and disseminate technical information relating to equipment, engineering, and GMPs.
- Responsible for preparation and presentation of project status reports Manage the design review, site acceptance, and installation of equipment.
- Prepare Piping & Instrumentation Diagrams and other related drawings and documents.
- Support QA/Validation Department through preparation of design documents and protocol review.
- Recommend and manage implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
- Evaluate, approve, prepare, and execute change control documentation Assist in development of department policies, procedures and specifications.
- Act as a Subject Matter Expert during regulatory inspections and internal investigations.
- Supports Manufacturing and Maintenance activities as technical advisor.
- Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
- Maintains company reputation by enforcing compliance with relevant laws, policies and regulations.
To be considered for this opportunity you should have a BS/BEng in Chemical, Process or Mechanical Engineering with 10+ years related experience. Direct experience with biopharmaceutical process equipment is required. Proven experience may be considered in lieu of the educational requirement. Formal training in project management is preferred.
For further information on this role in Senior Project Manager please contact Mark Kavanagh on firstname.lastname@example.org or 086 128 7513
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