Director, Commissioning and Start-Up Engineering

Position Summary: 

The Director of Commissioning and Start-Up Engineering is a senior leadership role responsible for establishing and executing commissioning qualification and start-up strategies for major capital projects facility expansions and new manufacturing operations. This role provides enterprise-level leadership to ensure assets are delivered safely compliantly and on schedule while meeting AbbVie quality operational and business objectives. The Director leads cross-functional teams and external partners through turnover readiness and operational handoff in highly regulated manufacturing environments. 

Key Responsibilities: 

• Lead the development and execution of comprehensive commissioning and start-up strategies for major capital projects and manufacturing expansions. 
• Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs. 
• Leads site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness. 
• Provide strategic direction for CQV readiness turnover governance and transition-to-operations planning. 
• Ensure commissioning and start-up activities align with AbbVies safety quality cost and schedule expectations. 
• Direct cross-functional teams across Engineering Validation Quality Operations Automation Maintenance Supply Chain and EHS. 
• Oversee readiness for utilities process systems cleanrooms automation platforms and supporting infrastructure. 
• Establish and maintain project governance milestone tracking risk management and escalation pathways. 
• Drive operational readiness activities including SOP development training staffing readiness maintenance planning spare parts strategy and documentation completion. 
• Manage third-party contractors consultants and integration partners to ensure execution quality and accountability. 
• Partner with site leadership and functional leaders to ensure successful transition from project delivery to stable operations. 
• Ensure all turnover commissioning and start-up activities comply with cGMP regulatory and EHS requirements. 
• Champion standardization continuous improvement and lessons learned across projects and sites. 
• Influence budget resource planning and strategic prioritization for commissioning and start-up efforts. 
• Serve as a senior escalation point for execution risks startup issues and readiness gaps. 

Qualifications :

• Bachelors degree in Engineering Pharmaceutical Sciences or a related technical discipline required; advanced degree preferred. 
• Typically 20 years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments. 
• Extensive leadership experience in commissioning qualification validation and plant start-up for complex facilities or capital projects. 
• Demonstrated success leading large cross-functional teams and managing multiple stakeholders in a matrixed organization. 
• Strong knowledge of cGMP regulatory expectations EHS standards and manufacturing quality systems. 
• Proven ability to lead major facility or process start-up efforts from design transfer through operational readiness. 
• Strong project leadership organizational and communication skills. 
• Ability to influence senior leaders and drive alignment across functions and business units. 

Preferred Qualifications: 

• Experience in sterile injectables biologics API or oral solid dose manufacturing. 
• Experience with risk-based CQV methodology and digital turnover systems. 
• Experience supporting global or multi-site capital project portfolios. 
• PMP Lean Six Sigma or equivalent leadership certification preferred. 

Leadership Competencies: 

• Strategic leadership 
• Enterprise mindset 
• Cross-functional influence 
• Accountability and decision-making 
• Change leadership 
• Operational excellence 
• Compliance and quality focus 

Work Environment This role may require travel to project and manufacturing sites and extended hours during critical commissioning and start-up phases. 

Key internal stakeholders for a Director of Commissioning and Plant Start-Up typically include: 

• Site Leadershipand Site Director overall site strategy priorities and operational readiness 
• EngineeringLeadership thru VP Level design execution utilities facilities and project delivery 
• Validation / CQVTeam commissioning qualification and validation strategy and execution 
• Quality Assuranceleadership thru VP Level cGMP compliance documentation and release readiness 
• EHS (Environmental Health & Safety)thru VP Level safe startup risk controls and compliance 
• Automation / IT / Digital Systems control systems data integrity MES and infrastructure readiness 
• Maintenance / Reliability(MEP) Team asset readiness PM strategy spares and maintainability 
• Project Management / PMOOrganization schedule scope budget and governance 
• Procurement / Strategic Sourcing thru VP Level contractor and vendor management 
• HR / Talent / Learning staffing training and organizational readiness 
• Finance budget tracking and capital spend governance 

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time