Piramal Group · 1 month ago
Manufacturing Process Engineer
1500 BULL LEA ROAD,, Lexington, KY, 40511, US
Full-time
Onsite
Mid Level
3+ years expPiramal Group is a leading company in Pharma Solutions, seeking a Manufacturing Process Engineer to provide process engineering support. This role involves designing and managing projects for systems and equipment, ensuring quality and compliance in the manufacturing process.
BiotechnologyHealth CareMedical
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
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
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
Experience with Allen-Bradley ControlLogix and Siemens PLCs
Experience with HMI software applications
Experience with automating processes and equipment
Company
Piramal Group
- Offices in over 30 countries - Brand presence in over 100 global markets - Team of over 10,000 people from 21 diverse nationalities Piramal Group is a global business conglomerate with diverse interests in Pharma, Financial Services, and Real Estate.
10001+ employees
H1B Sponsorship
Piramal Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (9)
2023 (12)
2022 (7)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageRecent News
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