Manufacturing Process Engineer

Piramal Pharma Ltd; Lexington (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manufacturing Process Engineer in Lexington, KY. You will serve as a subject-matter-expert, delivering project management, system implementation, and process improvements for facilities, utilities, and equipment.

Reporting to the Engineering Manager, you’ll ensure quality, compliance, and OTIF across products. You’ll support 24/7 operations, develop SOPs, and lead deviation investigations with a strong cGMP mindset.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering.
• 3–5 years of pharmaceutical manufacturing/maintenance experience (parenteral/sterile filling preferred).
• Expertise in troubleshooting production equipment/systems and understanding cGMPs (FDA/PMDA/EU).
• Experience with validation protocols and deviation investigations (CA/PA).
• Shift-flexible to support 24-hour operation with a 4-shift rotating schedule.

Responsibilities

• Designs and project manages changes, improvements, new systems and equipment.
• Prepares CCRs, design specs, user requirements specs, and validation documents.
• Leads continuous improvement projects and manages change control processes.
• Acts as SME in teams for installation, troubleshooting and maintenance.
• Supports day-to-day production and maintenance activities; provides training as needed.
• Develops and updates SOPs for processes and equipment.
• Participates in deviation investigations and root-cause analysis.
• Maintains technical drawings and the Publications Library.
• Manages operation and maintenance of validated systems to maintain production capability.

Skills

Troubleshooting

cGMP knowledge

PLC systems

SOP development

Documentation

Education

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

Tools

Allen-Bradley ControlLogix

Siemens PLCs

HMI software

Industrial networks

Job description

Be the First to Apply

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: 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.

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.

Bachelor’s Degree – Mechanical Engineering