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Pharmaceutical Facilities Engineer

Akorn, Inc Somerset, NJ Full-Time
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JOB DESCRIPTION

Akorn is seeking a Chemical / Mechanical Engineer to work on projects focused on mechanical systems to support its sterile pharmaceutical processes, aseptic filling operations and cleanroom HVAC design. This individual must have a background in mechanical engineering/HVAC/process utilities and a thorough understanding of engineering practice within FDA regulated industries. We are looking for a resourceful and goal-oriented individual who desires challenging work in a dynamic environment.

RESPONSIBILITIES

  • Provide mechanical engineering services supporting projects from conceptual through detailed design, commissioning and qualification of sterile pharmaceutical manufacturing facilities.
  • Interface with other designers and client representatives to supervise and coordinate the development of design deliverables.
  • Develop User Requirement Specifications for cleanroom HVAC system, designs and implementation of cleanroom particle monitoring systems, differential and cascade pressure designs for sterile facilities, process piping and plant utilities.
  • Develop equipment specifications, protocols and other design deliverables supporting facility capital expansions, renovations, new equipment and remediation projects.
  • Supply feasibility studies, concept development, safety/risk analysis, equipment/utilities capacity analysis and sizing.
  • Provide commissioning and troubleshooting support for equipment and utility systems.
  • Identification, analysis and recommendation of state-of-the-art facility / utility / equipment alternatives to current site technology – that represent potential quality, cost and / or productivity improvements.
  • Directing outside contractors for related engineering work.
  • Develops site / departmental Standard Operating Procedures (within the established quality system and change control process) as needed to address internal engineering programming criteria.

QUALIFICATIONS

  • Bachelor’s degree in Chemical or Mechanical Engineering required.
  • Minimum 3 years of mechanical, electrical and plumbing (MEP) engineering experience required.
  • Process engineering experience a plus.
  • Minimum of 3 years’ experience in the design of FDA regulated facilities is required with an emphasis on sterile facility design is preferred.
  • Experience with managing and executing GMP projects by overseeing external design and construction management firms, plant utilities, clean utilities, clean rooms, airlocks and HVAC equipment is desirable.
  • Knowledge of applicable codes and standards required
  • Strong computer literacy, good written & verbal communication skills.
  • Moderate to good proficiency with Microsoft Project, Word, Excel, and AutoCAD
  • EIT or Registered P.E. is a plus.

Skills required

Testing
Commissioning
Installations (Manual/Mechanical)
Troubleshooting (Problem Solving)
Engineering
Boilers
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Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, otics, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

Akorn has Research and Development facilities in Vernon Hills, IL; Warminster, PA; and Copiague, NY that provide a robust and continuous pipeline of new products. Akorn's manufacturing facilities are located in Decatur, IL; Somerset, NJ; Amityville, NY; Paonta Sahib, India; and Hettlingen, Switzerland.

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