Pharmaceutical Process Engineer Jobs in Michigan

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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

Job Description

Key responsibilities.

• Assesses and monitors equipment for reliability of operation implementing necessary improvements
• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification.
• Ensures that appropriate critical spares are in place where needed. Conduct regular Vital, Essential, Desirable analysis to determine what spares need to be kept in plant based on risk.
• Research and development of new equipment that can be used in the facility.
• Assist in preparation of Standard Operating Procedures detailing equipment operation, maintenance, and cleaning, as an integral part of the qualification package.
• Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.
• Review calibration documentation provided by other ASI departments and outside contractors.
• Maintain calibration Standard Operating Procedures, calibration records, and qualification of calibration contractor.
• Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters
• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.
• Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.
• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs
• Conducts Root Cause Investigations into equipment failures, and develops robust corrective actions.
• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization
• Participates in and execute qualification and validation of equipment and processes

Education/Experience.

• Bachelor's degree in an engineering discipline
• Minimum 3 years of experience in a related or similar field

Job Competencies.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.
• Technical aptitude: a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems used at an organization.
• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.
• Problem-solving: the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create effective corrective actions.
• Communication: the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.
• Project management: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.
• Data management skills: the ability to use statistical analysis tools to determine correlations between equipment performance/repair metrics and breakdown data, as well as the ability to interpret and communicate the results of the analysis.
• A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
• An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.
• Safety-conscious: the ability to identify potential hazards and take the necessary steps to mitigate them.
• Knowledge of CMMS system and functions
• Knowledge of the regulations and their application to the manufacturing processes