Manufacturing Process Engineer

Piramal Pharma Ltd; Lexington (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is seeking a Manufacturing Process Engineer to provide real-time process engineering support for manufacturing, including project design, and implementation of new and existing systems, utilities and equipment. You will ensure quality, compliance and OTIF for all products produced at the Lexington facility.

Reporting to the Engineering Manager, you will serve as SME in change control, validation, and continuous improvement, while supporting day-to-day

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering required.
• 3–5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred).
• Expertise in troubleshooting production equipment/systems.
• Ability to work a 4-shift rotating days-off schedule to support 24-hour operation.
• PC-literate with Word, Excel, PowerPoint competency.
• Experience with maintenance and administration of Windows-based and industrial networks.
• Experience with automated processes and equipment including HMI software.
• Knowledge of cGMPs including FDA, PMDA, and EU regulations and validation requirements.
• Knowledge/experience in cGMP CA/PA, root-cause analysis and risk assessment.

Responsibilities

• Designs and project manages changes, improvements, new systems or equipment.
• Prepares CCRs, Design Specifications, User Requirements Specifications, System Specifications, Design documents, drawings, and validation documents.
• Leads/assists in Continuous Improvement Projects, researching literature, vendors, and proposals.
• Represents Technical SME in teams to specify, install, troubleshoot and maintain systems, equipment, and processes.
• Supports day-to-day production and maintenance activities.
• Provides training support as required.
• Develops/modifies SOPs for processes and equipment.
• Participates in deviation investigations to identify root causes and corrective actions.
• Creates and maintains drawings and sketches.
• Manages Technical Publications Library for manuals, specs and design information.
• Maintains operation of Validated Systems to keep production capability; upgrades manufacturing related systems.
• Acts as first line for enhancements and upgrades of manufacturing systems.

Skills

Troubleshooting

Automation

Cross-functional

PLC experience

cGMP knowledge

Education

Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering

Tools

Allen-Bradley ControlLogix

Siemens PLCs

Job description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manufacturing Process Engineer

Job Description

Business: Pharma Solutions Department: Facilities, Maintenance & Engineering Location: LexingtonJob Description Business: Pharma Solutions Department: Facilities, Maintenance & Engineering Location: Lexington 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.