Job Description
0046V6305 Healthcare Project Manager (Shutdown)
Please contact Amanda Mazza,
[email protected] We are seeking an experienced and highly organized
Project Manager to lead and coordinate
shutdown activities for a nutrition manufacturing client facility. The successful candidate will be responsible for planning, executing, and closing out major shutdown events involving maintenance, engineering, validation, and process improvements while ensuring full compliance with cGMP, safety, and quality regulations.
This role is critical in minimizing downtime, managing multi-disciplinary teams, and delivering shutdown activities on time, within budget, and with zero compromise to product quality or patient safety.
Key Responsibilities - Lead the end-to-end planning and execution of nutrition plant shutdowns (annual), including scope definition, scheduling, resource allocation, and risk management.
- Develop detailed shutdown schedules using Primavera P6, Microsoft Project, or equivalent tools, incorporating critical path activities, dependencies, and contingency plans.
- Coordinate cross-functional teams including Maintenance, Engineering, Validation, Quality Assurance, Production, EHS, and external contractors/vendors.
- Ensure all shutdown activities comply with cGMP, FDA/EMA regulations, ICH guidelines, and internal quality standards.
- Manage shutdown budget preparation, cost tracking, and financial reporting. Identify and implement cost-saving opportunities without compromising compliance or safety.
- Conduct risk assessments, develop mitigation strategies, and maintain a robust shutdown risk register.
- Oversee preparation and execution of change controls, validation protocols, and documentation required for shutdown-related activities.
- Manage contractor onboarding, safety inductions, permitting systems (Hot Work, Confined Space, LOTO, etc.), and performance monitoring.
- Lead daily/weekly shutdown coordination meetings, progress reviews, and issue resolution.
- Ensure all work is completed safely, with a strong focus on behavioral safety and zero lost-time incidents.
- Drive post-shutdown review (lessons learned), performance metrics analysis, and continuous improvement initiatives for future shutdowns.
- Track and report key performance indicators (KPIs) including schedule adherence, budget variance, safety performance, and quality compliance.
Required Qualifications & Experience - Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field. Master’s degree preferred.
- Minimum 8–10 years of project management experience in a regulated manufacturing environment .
- Proven track record successfully managing plant shutdowns of similar scale and complexity.
- Strong knowledge of cGMP, FDA, EMA, and other regulatory requirements related to maintenance and validation activities.
- Professional certification preferred: PMP (Project Management Professional) , PRINCE2, or equivalent.
- Proficiency in project management tools (Primavera P6 highly preferred, MS Project, or similar).
- Experience with Computerized Maintenance Management Systems (CMMS) such as SAP, Maximo, or equivalent preferred.
- Demonstrated ability to manage large teams and multiple contractors simultaneously during high-pressure shutdown periods.
Essential Skills & Competencies - Excellent leadership and stakeholder management skills – ability to influence without direct authority.
- Strong analytical, problem-solving, and decision-making abilities under tight timelines.
- Superior communication and presentation skills (written and verbal).
- High attention to detail with the ability to manage complex, interdependent activities.
- Solid understanding of manufacturing processes, equipment, and utilities (HVAC, WFI, Clean Steam, Compressed Air, etc.).
- Ability to work flexible hours, including nights, weekends, and extended shifts during shutdown execution.
- Results-oriented with a strong sense of ownership and accountability.
LOCATION Casa Grande, AZ EMPLOYMENT C2C or W2
Job Tags
For contractors, Flexible hours, Night shift