Manufacturing Process Engineer

Manufacturing Process Engineer Piramal Pharma Solutions - 3.6 Lexington, KY Job Details Full-time Up to $100,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Parental leave Employee assistance program Vision insurance 401(k) matching Life insurance Referral program Retirement plan Qualifications Chemical Engineering Computer literacy Maintenance Bachelor's degree Electrical Engineering Process engineering Full Job Description Company Overview Piramal Pharma Solutions (PPS) is a leading Contract Development and Manufacturing Organization (CDMO) dedicated to delivering comprehensive solutions across the entire drug development and manufacturing spectrum. With a global network of state-of-the-art facilities, we specialize in innovative pharmaceutical services, including biologics, potent APIs, sterile fill/finish, and advanced manufacturing technologies. Our commitment is to partner with clients worldwide to bring life-changing therapies to market efficiently and reliably. Job Overview Reporting to the Engineering Manager, the Manufacturing Process Engineer serves as subject-matter-expert and provides real-time, process engineering support to the manufacturing process. This position is responsible for design, project management, and implementation of new and existing systems, utilities and equipment, and ensures Quality, Compliance, and improved OTIF for all products produced at the manufacturing facility in Lexington, Kentucky. Reporting Structure This position reports to the Engineering Manager.

Key Responsibilities:

Designs and project manages changes, improvements, new systems and or equipment. Prepares Change Control Records (CCRs), Design Specifications, User Requirements Specifications, System Specifications, Design documents, Drawings, and Validation Documents for improvement, planned and corrective maintenance and system or process improvements Leads/assists in Continuous Improvement Projects, including identification of opportunities, researches literature and vendors, prepares and presents proposals, develops and executes projects, and closes projects, all following appropriate change control methodologies Represents Technical Subject Matter Expert (SME) in teams assembled to specify, install, troubleshoot and maintain systems, equipment and processes Supports day-to-day production and maintenance activities Provides training support as required. Develops and or modifies SOPs for the Processes and Equipment. Participates in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA). Creates and maintains drawings and sketches. Manages Technical Publications Library to ensure the relevant manuals, specifications, design information for all of our facilities, utilities, equipment and products are on hand Primary/First Line responsibility for operation and maintenance of the Validated Systems to maintain production capability required. Primary/First Line responsibility for enhancements and upgrades of manufacturing related systems to maintain production capability.

Qualifications:

Bachelor's degree in Mechanical, Electrical, or Chemical Engineering Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred) Expertise in troubleshooting production equipment/systems Ability to work flexible schedule to support 24-hour operation (requires assignment on shift for 4 shift rotating days off schedule) PC literate with standard office application (Word, Excel, PowerPoint) competency Experience with maintenance and administration of both Windows-based and industrial (e.g., PLC) computer networks. Experience with Allen-Bradley ControlLogix and Siemens PLCs; experience with HMI software applications; experience with automating processes and equipment Knowledge and understanding of cGMPs including FDA, PMDA, and EU regulations; knowledge of cGMP validation requirements and techniques; experience with commissioning and validation protocol development and execution. Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.

Pay:

Up to $100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Referral program Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person