Associate Director, Commissioning and Start-Up Engineering

Associate Director Commissioning and Start-Up is responsible for providing operational leadership for commissioning qualification and start-up activities supporting new manufacturing sites facilities expansion utilities equipment and related systems. This role ensures assets are delivered safely compliantly and on schedule in a state of readiness for GMP operations while meeting Abbvie quality operational and business objectives. The Director leads cross-functional teams and external partners while enabling a smooth transition from project execution to sustained operational performance.

Key Responsibilities

• Provide leadership for commissioning qualification and start-up activities across facilities utilities equipment and supporting systems.
• Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.
• Develop align and execute commissioning and start-up strategies plans schedules protocols and turnover packages.
• Ensure readiness of systems for GMP operations in compliance with applicable regulatory quality safety and company standards.
• Partner cross-functionally with engineering validation manufacturing quality EHS automation project management and third-party contractors to deliver integrated startup execution.
• Manage risks dependencies timelines budgets and issue resolution throughout the project lifecycle.
• Support and oversee site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness. 
• Lead troubleshooting and corrective action efforts during startup to support successful implementation and stable operations.
• Lead operational readiness and the successful integration of new assets into routine site operations.
• Support budgeting resource planning for commissioning and start-up efforts.

Qualifications :

• Bachelors degree in Engineering Pharmaceutical Sciences Life Sciences or a related technical discipline required; advanced degree preferred.
• Typically 12 years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments.
• Broad experience in commissioning qualification start-up validation or operational readiness.
• Demonstrated experience leading cross-functional teams. Ability to manage multiple priorities work through ambiguity and drive execution in a matrixed organization.
• Strong track record of delivering results in a GMP-regulated environment.
• Strong project leadership organizational and communication skills.
• Ability to influence and drive alignment across functions and business units.

  Preferred Qualifications

• Experience supporting facility expansions new product introductions or major capital projects.
• Experience in sterile injectables biologics API or oral solid dose manufacturing.
• Experience with risk-based CQV methodology and digital turnover systems.
• Prior people leadership experience in a matrixed global or highly collaborative environment.

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