Process Engineer


Job ID 19-00018

Industry Pharma

Job Type Permanent

Location Buena, NJ

Description

Job Summary:
This individual will support both topical and sterile/aseptic manufacturing activities. The Process Engineer will play a critical role in improving current facility and formulation and filling process operations. They will play a key role in the commissioning, qualification and validation of the facility, utilities, and process equipment. This position is a key member on a cross-functional team, which will provide processing leadership for projects involving existing and new manufacturing processes and products. This includes support for process design and scale-up, process technology transfer, validation and launch of new products, implementation of significant process improvements, equipment optimization, identification and resolution of process issues, post-launch optimization of products.
Essential Responsibilities:

  • Support technical activities related to new and existing products, process optimization, process and equipment troubleshooting and process validation
  • Collaborate with process engineers and development scientists to design and transfer robust manufacturing processes to commercial and third-party manufacturing operations
  • Support activities relating to change of processes, components and raw materials utilizing Change Control procedures
  • Support investigations relating to manufacturing issues, product release performance and or customer complaints
  • Identify projects to improve yield, lower costs and improve efficiency
  • Support multiple process engineering projects and process validation initiatives
  • Support internal and external auditors and regulatory agencies as needed during inspections
  • Provide data gathering and analysis as needed to support technical projects
  • Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations
  • Perform activities associated with the design and qualification of new and existing equipment used in manufacturing
  • •Support the implementation, commissioning, and validation of process equipment and rooms for sterile/aseptic filling, including the use of isolators
  • Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error(s)
  • Update drawings and P&ID to reflect changes to existing processes
  • Responsible for trouble shooting and providing corrective action directives
  • Troubleshoot process equipment and ensure utilities and equipment meet operating specifications
  • Write standard operations procedures, standard test procedures, master batch records and other related GMP documents


Qualifications

Qualifications:

  • BS degree in Engineering (Electrical, Mechanical, Chemical, etc.) or Science discipline and a minimum of 5 years of industrial experience
  • Operational experience in a pharmaceutical sterile and/or aseptic fill manufacturing environment preferred
  • Understanding of engineering fundamentals
  • Technical knowledge of processes/equipment
  • Excellent written and oral communication skills
  • Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
  • Advanced computer knowledge, including Microsoft Word and Excel
  • Communicate effectively with ability to function in a team environment
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Detail oriented with the ability to troubleshoot and resolve equipment problems
  • Proficient in reading schematics, diagrams, P&ID's and other written materials
  • High level of safety awareness