Our client is currently seeking a Process Engineer to join their team. This position is a 12+ month contract and onsite only in the greater Cleveland, OH area.
The Process Engineer, RTU supports all aspects of within the RTU bag filling operations unit including monitoring equipment design and fabrication, start-up, qualification, troubleshooting and continuous improvement. The Process Engineer has an integral role in supporting equipment commissioning and qualification, development of cGMP operating procedures, and supports ongoing capabilities of operations. The engineer will implement and support operation equipment and processes by ensuring current design practices and cGMPs are followed. Additionally the engineer will drive continuous improvement through process optimization, process troubleshooting, training, development of equipment specifications/upgrades, and the implementation of innovative new quality and compliance approaches.
- Act as lead for purchase, installation, start-up and commissioning of the compounding system.
- Work cooperatively with automation, operations, maintenance, validation and quality to meet project goals and objectives.
- Lead the generation and review of specifications for equipment and processes such as User Requirements (URS), Functional Design Specification (FDS), Hardware Design Specification (HDS) and Software Design Specification (SDS).
- Lead the generation and review of Process Flow Diagrams (PFD), Process & Instrumentation Diagrams (P&ID) and equipment arrangements.
- Assists in the development and execution of strategies for qualification and validation activities.
- Lead/Perform/Assists in factory acceptance testing, site acceptance testing, design, installation, operation, and performance qualification of equipment and process; including protocol generation, execution and report generation.
- Act as a subject matter expert for RTU production equipment and processes.
- Provides technical support for problems and projects related to manufacturing operations, environmental containment, facilities design, personnel and facility safety, and regulatory issues.
- Develop knowledge of and understand regulatory requirements of FDA, OSHA and other regulatory agencies.
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
- Oversee that processes are in cGMP compliance, and establish systems that identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness to heighten quality.
- Supports root cause analysis and provides technical CAPA review, and approves any necessary investigational reports to facilitate rapid closure of deviations and ensure actions are taken to prevent recurrence.
- Demonstrated skills in troubleshooting critical process or equipment issues.
- The individual will be working hands on with the equipment, executing tests and collecting data. Expected to spend time on the shop floor, and be trained in the appropriate gowning.
- Carry out problem solving on the production floor involving relevant stakeholders.
- Make sure daily production is running optimally, both in terms of output and quality.
- Identifies and drives opportunities for improvement, making constructive suggestions to improve process effectiveness, product quality and operating efficiency.
- Basic understanding of change management practices in a regulated, controlled environment.
- Able to effectively work in a dynamic environment where coordination with other functional groups is necessary. Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities while meeting high quality requirements within a tight schedule.
- Provides leadership, oversight, coordination, administration, and design input for multiple projects, ensuring that all internal customers and company objectives are met in accordance with established company project management practices and procedures.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
- Bachelor degree in Engineering (Preferred, not required)
- Minimum 3 years of experience in a pharmaceutical manufacturing environment.
- Availability to travel as required to carry out responsibilities such as design reviews, FAT, etc.
- Hands-on experience with pharmaceutical equipment and processes.
- Demonstrated ability to communicate effectively
- Experience with aseptic processing preferred
- Experience with change control process and equipment qualification preferred.
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User Requirements Documents