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Piramal Pharma Ltd · 3 hours ago

Manufacturing Process Engineer

Lexington, KY

Full-time

Onsite

Mid Level

3+ years exp

Piramal Pharma Ltd is a Contract Development and Manufacturing Organization (CDMO) offering comprehensive services in the pharmaceutical sector. The Manufacturing Process Engineer will provide process engineering support, manage projects, and ensure compliance and quality in the manufacturing processes at the Lexington facility.

BiotechnologyConsumer GoodsHealth CareManufacturingPharmaceutical

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

Qualification

Pharmaceutical manufacturing experienceTroubleshooting production equipmentCGMP knowledgeMechanical Engineering degreePLC experienceHMI software applicationsRoot-cause analysisRisk assessmentProject managementSoft skills

Required

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

Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience required

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

Preferred

Parenteral/sterile filling experience preferred

Company

Piramal Pharma Ltd

Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global facilities, which include end-to-end development and manufacturing capabilities, and a distribution network in over 100 countries.

Founded in 2020

Mumbai, Maharashtra, IND

10001+ employees