Piramal Pharma
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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.
The Manager, Facilities & Engineering develops and executes the site capital plan, ensures the effectiveness of maintenance and reliability programs, supports regulatory and customer audits, and provides engineering leadership to enable safe, compliant, and efficient manufacturing operations. Engineering support for new customer projects is focused on facility readiness, utility capacity, equipment suitability, containment considerations, materials of construction, and qualification requirements.
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.
Instrumentation & Controls
Provide oversight of instrumentation, automation, PLC, SCADA, and building management systems.
Ensure control systems remain reliable, secure, and compliant with applicable requirements.
Support automation improvements that enhance reliability, safety, and operational efficiency.
Manufacturing Support
Provide engineering support for manufacturing operations.
Troubleshoot facility, utility, equipment, and process-related issues.
Support production continuity through timely resolution of engineering issues.
Partner with manufacturing teams to improve safety, quality, compliance, and productivity.
New Project & Technology Transfer Support
Assess facility readiness for new customer projects and technology transfers.
Evaluate utility capacity, equipment capability, containment requirements, and materials of construction.
Identify facility modifications or capital investments required to support new programs.
Support commissioning, qualification, and startup activities associated with new equipment and facility modifications.
Regulatory, Quality Customer Audit & Inspection Support
Serve as engineering subject matter expert during customer audits and regulatory inspections.
Support responses to engineering-related observations and commitments.
Ensure engineering systems are maintained in an inspection-ready state.
CAPA and Deviation resolution
Operational Excellence
Identify and implement continuous improvement initiatives.
Support equipment reliability, energy reduction, cost savings, and productivity improvement programs.
Utilize Lean, Six Sigma, and problem-solving methodologies to improve engineering performance.
Develop and monitor engineering KPIs related to reliability, maintenance, project execution, compliance, and cost performance.
Contractor & Vendor Management
Manage engineering contractors, consultants, and service providers.
Lead technical evaluations and selection of engineering equipment and services.
Ensure contractor activities are performed safely and in accordance with GMP and site requirements.
Other duties as assigned
Required
Bachelor's Degree or Higher in Chemical Engineering,
Minimum eight (8) years of experience in pharmaceutical, biotechnology, chemical, or other regulated manufacturing environments.
Experience leading engineering teams and technical professionals.
Experience supporting GMP manufacturing facilities, utilities, and process equipment.
Experience managing capital projects and engineering budgets.
Strong knowledge of FDA, cGMP, OSHA, EPA, and applicable industry regulations.
Experience with equipment qualification and validation programs.
Strong technical troubleshooting and problem-solving skills.
Advanced degree in Engineering, or additional degree Science, or Business.
Project Management Professional (PMP) certification.
Lean Six Sigma certification.
Experience supporting HPAPI, API, or pharmaceutical manufacturing facilities.
Experience with automation, controls, and digital manufacturing technologies.
Core Competencies
Engineering Leadership
Strategic Planning
Capital Project Management
Facilities & Utility Systems Management
Reliability Engineering & Asset Management
GMP Compliance & Validation
Process Safety & Mechanical Integrity
Operational Excellence (Lean Six Sigma)
Root Cause Analysis & Problem Solving
Budget & Resource Management
Change Management
Cross-Functional Leadership
Communication & Influence
Contractor & Vendor Management
Regulatory Inspection & Customer Audit Support
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