Manager, Engineering

piramalpharma; Town of Riverview (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager, Engineering at our HPAPI Research and Manufacturing site in Riverview. The role leads a multidisciplinary engineering team to ensure reliability, compliance, safety, and operational readiness of facilities, utilities, and manufacturing equipment in a GMP environment.

The position oversees project engineering, validation engineering, calibration, instrumentation & controls, and technical troubleshooting, directing resources across capital projects,

Responsibilities

• Lead, mentor, and develop a multidisciplinary engineering team.
• Establish departmental objectives , priorities, and performance metrics.
• Develop engineering succession plans and organizational capability.
• Allocate engineering resources across manufacturing support, capital projects, validation activities, and continuous improvement initiatives.
• Serve as the engineering representative on site leadership teams.
• Provide engineering leadership for process safety, containment systems, and mechanical integrity programs supporting HPAPI and API manufacturing operations.
• Conduct performance management, coaching, development planning, and talent assessment activities for engineering personnel
• Provide technical ownership of site facilities and utility systems.
• Ensure facility and utility systems are maintained in a compliant and reliable state.
• Support facility expansion, renovation, and infrastructure improvement projects.
• Maintain long-range plans for facility and utility capacity to support business growth.
• Ensure utility systems are capable of supporting current and future manufacturing requirements.
• Establish and maintain equipment reliability programs.
• Develop maintenance strategies that maximize equipment uptime and performance.
• Ensure preventive and predictive maintenance programs are effective and risk based.
• Lead investigations and root cause analyses for significant equipment failures.
• Develop life-cycle plans for critical manufacturing assets.
• Ensure appropriate spare parts and obsolescence management strategies are maintained .
• Develop and maintain the site capital investment plan.
• Prepare project justifications, scope documents, budgets, and capital requests.
• Manage engineering projects from concept through commissioning and qualification.
• Ensure projects are executed safely, on schedule, within budget, and in compliance with site requirements.
• Coordinate engineering activities with manufacturing, quality, validation, and supply chain organizations.
• Own the engineering operating budget and capital expenditure budget, ensuring effective allocation of resources and achievement of financial objectives .
• Develop and maintain the site facilities master plan to support current operations and future business growth.
• Ensure engineering systems, equipment, and utilities are appropriately qualified and maintained in a validated state.
• Review and approve engineering-related validation documentation.
• Support deviation investigations, CAPAs, change controls, risk assessments, and quality systems.
• Ensure engineering documentation and equipment records are accurate , complete, and inspection-ready .

Job description

Division

Piramal Pharma Solutions 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

Manager, Engineering Job Description

Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Manager, Engineering. The Manager, Facilities & Engineering is responsible for ensuring the reliability, compliance, safety, and operational readiness of site facilities, utilities, and manufacturing equipment within a GMP pharmaceutical manufacturing environment. The position leads a multidisciplinary engineering organization responsible for project engineering, process engineering support, validation engineering, calibration, instrumentation & controls, facility engineering, and technical troubleshooting.

Key responsibilities.

Leadership & Organizational Development

• Lead, mentor, and develop a multidisciplinary engineering team.
• Establish departmental objectives , priorities, and performance metrics.
• Develop engineering succession plans and organizational capability.
• Allocate engineering resources across manufacturing support, capital projects, validation activities, and continuous improvement initiatives.
• Serve as the engineering representative on site leadership teams.
• Provide engineering leadership for process safety, containment systems, and mechanical integrity programs supporting HPAPI and API manufacturing operations.
• Conduct performance management, coaching, development planning, and talent assessment activities for engineering personnel

Facilities, Utilities & Infrastructure

• Provide technical ownership of site facilities and utility systems.
• Ensure facility and utility systems are maintained in a compliant and reliable state.
• Support facility expansion, renovation, and infrastructure improvement projects.
• Maintain long-range plans for facility and utility capacity to support business growth.
• Ensure utility systems are capable of supporting current and future manufacturing requirements.

Equipment Reliability & Asset Management

• Establish and maintain equipment reliability programs.
• Develop maintenance strategies that maximize equipment uptime and performance.
• Ensure preventive and predictive maintenance programs are effective and risk based.
• Lead investigations and root cause analyses for significant equipment failures.
• Develop life-cycle plans for critical manufacturing assets.
• Ensure appropriate spare parts and obsolescence management strategies are maintained .

Engineering Project Management

• Develop and maintain the site capital investment plan.
• Prepare project justifications, scope documents, budgets, and capital requests.
• Manage engineering projects from concept through commissioning and qualification.
• Ensure projects are executed safely, on schedule, within budget, and in compliance with site requirements.
• Coordinate engineering activities with manufacturing, quality, validation, and supply chain organizations.
• Own the engineering operating budget and capital expenditure budget, ensuring effective allocation of resources and achievement of financial objectives .
• Develop and maintain the site facilities master plan to support current operations and future business growth.

Validation & Engineering Compliance

• Ensure engineering systems, equipment, and utilities are appropriately qualified and maintained in a validated state.
• Review and approve engineering-related validation documentation.
• Support deviation investigations, CAPAs, change controls, risk assessments, and quality systems.
• Ensure engineering documentation and equipment records are accurate , complete, and inspection-ready .