Location: Buena, NJ
To provide a safe and healthy work environment for all of our employees and contractors, Teligent has mandated that all employees be fully vaccinated for COVID-19. This means that all new hires will be required to be fully vaccinated prior to their start date. We are taking this proactive step as our community continues to be negatively impacted by the pandemic and the surging Delta variant. Should you require a religious or medical accommodation, please inquire about necessary steps to secure such accommodations.
Essential Duties and Responsibilities:
The Process Engineer will support both topical and sterile/aseptic manufacturing activities and will play a critical role in improving current facility and formulation and filling process operations. Additionally, 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 that 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.
- 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.
Education and/or Work Experience Requirements:
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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.