Engineering Project Manager
Xellia

Cleveland, Ohio

Posted in Pharmaceuticals


This job has expired.

Job Info


The Engineering Project Manager will provide technical and strategic expertise in terms of manage Improvements and CAPEX projects for the site. The Project Portfolio will be in on a scale of $10K and above. Incumbent will be responsible of manage the Capex Project Portfolio of Cleveland site. The Engineering Project Manager will be responsible for developing the overall project schedule of site projects, manage CAPEX budget, expense, and prepare required reports for management. Establish the strategies for project implementation and track project progress through project completion.Lead the Project Engineers of the site. Provide technical support in the project management of their assigned projects.

Teamwork with Operations, Quality, MS&T/Validations, Maintenance, Automation, Facilities & Utilities, and Site Leadership Management to ensure successful projects completion. This position will play a key role in all stages of the engineering project and equipment lifecycle from conceptual design, detailed design, specification, implementation, and commissioning.

Key Responsibilities

  • Project management of Engineering projects using traditional as well as agile Project management methodologies within the pharma and/or process industry
  • Prepare project plans for manufacturing equipment or facility improvements, including timelines, budgetary estimates, or capital spending requests.
  • Communicate with suppliers regarding the design or specifications of equipment, instrumentation, or materials.
  • Developing projects' scope and objectives, ensuring technical feasibility.
  • Manage and set priorities for specific projects.
  • Collect, plan, track, and report on KPIs across the project.
  • Manage budget for project tracks & report these accordingly.
  • Monitor timelines to ensure that the milestones and deliverables within the project plan are met as agreed.
  • Prepare, distribute & present project status reports to project team members and management.
  • Effectively manage stakeholder expectations.
  • Coordinate communications pertaining to project management.
  • Identify and escalate critical issues impacting project timelines, scope, and budget.
  • Generate & review project plans, process descriptions.
  • Facilitate and coordinate program activities across the project.
  • Generate and review documentation supporting project management such as presentations for the organization & upper stakeholder management.
  • Identify opportunities or implement changes to improve manufacturing processes or products or to reduce costs, using knowledge of fabrication processes, tooling and production equipment, assembly methods, quality control standards, or product design, materials, and parts.
  • Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
  • Incorporate new manufacturing methods or processes to improve existing operations.
  • Review product designs for manufacturability or completeness.
  • Purchase equipment, materials, and parts.
  • Provide overall support to ensure that project is executed to the highest quality standards.
  • Partner with Quality to monitor and ensure processes and products comply with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA, EPA, and other regulatory agencies.
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Wear Personal Protective apparel, such as but not limited to head, face, hand, and arm coverings, shall be worn as necessary to protect you and the drug products from contamination.

Qualifications
  • Bachelor's Degree of Engineering, Mechanical, Electrical, or Chemical is required or a minimum of 10 years of experience Project Management field on the pharmaceutical or medical device environment.
  • Experience with Construction Management is highly preffered
  • Experienced in problem solving with emphasis on strong interpersonal skills necessary to interact across various functional groups
  • Self-motivation and flexibility to learn and respond to changing responsibilities and priorities, while meeting high quality requirements and adhering to a tight schedule
  • Experience in managing commissioning, qualification and validation projects in pharmaceutical production is necessary.
  • Availability to travel, as required, to carry out responsibilities such as design reviews and FAT
  • Exhibit a continuous improvement mindset, high level attention to details and advance organizational skills. Be able to make sound decisions when faced with competing priorities.
  • Fluent with Project Management tools such as MS Project for scheduling, TEAMs, and Smartsheet for group/team communications.
  • Excellent verbal and written communication skills

Physical Requirements of the Role

Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 25 lbs. Standing, walking, bending over and repetitive use of legs are done occasionally. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here


This job has expired.

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