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.
- 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.
- 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.
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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.
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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.