Manufacturing Process Engineer

JOB DESCRIPTION

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.

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.

Education Experience:

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

Work Experience:

• Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred)

Functional or Technical Skills:

• 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.

ABOUT US

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

ABOUT THE TEAM

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.