Manufacturing Process Engineer

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

Job summary

Piramal Pharma Solutions is a leading CDMO with facilities worldwide, providing end-to-end development and manufacturing services for APIs and finished dosage forms. This role supports design, project management, and implementation of systems and equipment at the Lexington, KY site to ensure quality and on-time production.

The Manufacturing Process Engineer will work with Engineering, Maintenance, and QA teams, driving improvements, validations, and SOP updates to support 24/7 operations and

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering.
• Minimum 3–5 years of pharmaceutical manufacturing/maintenance experience.
• Experience with cGMPs including FDA, PMDA, EU regulations.

Responsibilities

• Designs and project manages changes, improvements, new systems or equipment.
• Prepares CCRs, design specs, user requirements, system specs, and validation documents.
• Leads continuous improvement projects following change control methodologies.
• Represents SME in teams to specify, install, troubleshoot and maintain systems.

Skills

Troubleshooting

Process engineering

Documentation

Cross-functional collaboration

Education

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

Bachelor’s Degree – Mechanical Engineering

Tools

Allen-Bradley ControlLogix

Siemens PLCs

HMI software

Job description

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

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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.