Process Excellence Engineer

Job Description

Key responsibilities.

• Responsible for working with Technology Transfer, Production, and the Client to generate, revise, and approve master production records (MPRs) and any other documents associated with the commercial products in the manufacturing, e.g., SOPs, material specifications, technical reports, etc.
• Preparing unplanned and planned deviations for responsible processes and forming the investigation team.
• Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure.
• Work with project and engineering teams to replace existing/modify or buy equipment’s for continuous improvement or capacity enhancement
• Functions as the technical interface between PPS-Riverview and the Client, focusing on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries.
• Will require solid understanding of manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and complete understanding of production processes in the GMP environment as laid out at PPS-Riverview. Willingness to work flexible hours and shifts when there is a need.
• Responsible for providing independent production support during off-hours as needed.
• Ability to travel as needed.
• Ensures process data is being updated on a monthly basis and analysis manufacturing KPI performance for improvement and discussion with the client.
• Takes part in Operational Excellence activities for the plant.
  
  

KEY INTERACTIONS.

• Production
• Technology Transfer
• External Clients
• Project Management
  
  

Education/Experience.

• Bachelor’s Degree in Chemistry or Engineering or a similar discipline is required with at least 0-3 years of relevant experience. Additional Masters or Ph.D. is preferred in lieu of some experience.
• Demonstrated project management and technical leadership capabilities.
• Confident management of internal and external stakeholder relationships.
• Good written and oral communication skills.
• Demonstrated teamwork skill and professionalism in all interactions.
• Proven track record of successful technology transfer.
• Working knowledge of process and desktop computers.
  
  

COMPLIANCE.

• Compliance with 21 CFR - Parts 210/211, EU Directives 91/356/EEC and ICH Q7.
• Compliance with SOPs, batch records, forms, logs of use and Quality Agreements.
• Recognizes common sources of failure and improves documentation to reduce deviations and errors.
• Works with Operations Personnel to improve compliance.
• Ensures work is in compliance with all state and federal regulations, including but not limited to OSHA, GMP, DEA, FDA, etc. Assists in the formulation of corrective procedures when needed.
• Uses appropriate PPE while inside a manufacturing area.
• Assumes responsibility for safety and knows appropriate emergency procedures in case of emergency.
• Knows the location of SDS binders and understand how the guidelines pertain to employees.
  
  

JOB CONDITIONS

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

• Physical Demands:
• Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
• Long periods of standing and walking can be expected in this position.
• This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Work Environment:
• Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
• Potential limited exposure to hazardous chemicals.
• Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.