Process Engineer

Location: Buena, NJ

Job Summary

The Process Engineer will support the current operation and the ongoing expansion of Teligent’s pharmaceutical manufacturing facility. The Process Engineer will support both topical and sterile/aseptic manufacturing activities. The Process Engineer will play a critical role in improving current facility and process operations. They will also support operations during the construction and phased transition into the facility expansion.  They will play a key role in the commissioning, qualification and validation of the new facility, utilities, and process equipment.

Essential Responsibilities

  •  Support technical activities related to new and existing products, process optimization, process and equipment troubleshooting and process validation
  • Manage, analyze and identify trends in data
  • 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
  • Participate in project teams to execute project goals and assignments
  • Support internal and external auditors and regulatory agencies as needed during inspections
  • Provide data gathering and analysis as needed to support technical projects
  • Analyze and improve material and personnel flow paths in the new facility to optimize facility start-up time and effort
  • Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations
  • Support the facility expansion and serve a leading role in planning and bringing new equipment and utilities on-line
  • 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)
  • Support strategic plans for process and plant improvements in order to increase efficiency and manage costs
  • Create new process and equipment drawings to existing processes based on specifications and standards
  • 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
  • Maintain a safety-first approach to process development and manufacturing

Qualifications

  •  BS degree in Engineering (Electrical, Mechanical, Chemical, etc.) or Science discipline
  • At least 5 years of process engineering or operations experience in a pharmaceutical sterile and/or aseptic fill manufacturing environment
  • Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
  • Experience performing and/or supporting equipment and utility qualifications and validations
  • Understanding of engineering fundamentals
  • Technical knowledge of processes/equipment/utilities (e.g. batch processing, filtration, lyophilization, purified water system, HVAC, etc.)
  • Excellent written and oral communication skills
  • Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
  • Basic 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

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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