Project Engineer
Xellia

Cleveland, Ohio

This job has expired.


The ProjectEngineer (PJE)will support the Engineering and Maintenance Department providing 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. PJE will be responsible for developing project schedule, coordinate execution and track project progress through project completion. PJE will be responsible for developing, tracking, and managing project budget. Teamwork with Operations, Quality, MS&T/Validations, Maintenance, Automation, Facilities & Utilities, and Site Leadership Management to ensure successful projects completion.

Key Responsibilities

  • Lead assigned projects
  • Generate capital approval request as required
  • Lead (Write/review)the generation of the project User Requirements (URS). Ensure alignment with all project stake holders
  • Lead the review/ approval of the project Engineering Documentation by the stake holders such as Functional Design Specification (FDS), Hardware Design Specification (HDS), Software Design Specification (SDS), Process Flow Diagrams (PFD), Process & Instrumentation Diagrams (P&ID), etc.
  • Develop and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and commissioning as applicable for the assigned projects
  • Continuously upgrade personal technical skill levels to assure application of best available technology and techniques for addressing site needs
  • Team with required departments to coordinate project implementation actives are efficiently scheduled
  • Communicate with suppliers regarding the design or specifications of equipment, instrumentation, or materials
  • 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
  • Provide periodic updates to Site Management regarding project status and progress
  • Evaluate and/or recommend equipment modifications to improve equipment reliability as part of Engineering Projects for scheduled and/or planned implementation
  • Other related duties as assigned to meet departmental and Company objectives
  • Partner with Quality to monitor and ensure processes and products are in compliance 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

Requirements

  • Bachelor's Degree of Engineering is required. Mechanical, Electrical, or Chemical is preferred with a minimum of 5 years of experience in a related field on the pharmaceutical or medical device environment.
  • Demonstrated ability to read, comprehend and interpret equipment manuals, P&ID's, mechanical and electrical drawings.
  • 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
  • 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 a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn


This job has expired.

Get Hired Faster

Subscribe to job alerts and upload your resume!

*By registering with our site, you agree to our
Terms and Privacy Policy.

More Pharmaceuticals jobs


Zoetis
Lincoln, Nebraska
Posted about 7 hours ago
Zoetis
Parsippany-Troy Hills, New Jersey
Posted about 7 hours ago
Zoetis
Parsippany-Troy Hills, New Jersey
Posted about 7 hours ago
View Pharmaceuticals jobs ยป