Commissioning and Qualification Manager

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose:

The Commissioning and Qualification (C&Q) Manager will be responsible for leading and executing commissioning and qualification activities for new and existing facilities, utilities and process equipment systems in compliance with regulatory, local and industry standards. This role is to ensure that all systems are installed, tested, and operate according to the design intent and user requirement specifications. The C&Q manager must work with site core functional teams on integrated schedules, resourcing management, and C&Q execution. They must onboard and manage a team of highly skilled C&Q subject matter experts to drive the project in line with the schedule. This role will be based at the AbbVie Barceloneta site (ABL) to support an aseptic fill finish program delivered by Global Engineering.

Responsibilities:

• Lead, motivate, supervise and drive the commissioning and qualification team, providing technical guidance and leadership throughout the project lifecycle.
• Support onboarding of C&Q subject matter experts with the Global Engineering program leads.
• Develop and implement commissioning and qualification strategies, ensuring adherence to company policies and regulatory guidelines (e.g., FDA, GMP).
• Planning and coordination of C&Q activities in line with a risk-based approach (RBV).
• Deliver program updates to both senior management and senior leadership as required.
• Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs. Manage metrics on a weekly basis to ensure C&Q earned value (EV) week on week is tracked. 
• Coordinate with engineering, quality, operations, maintenance, and external vendors to ensure project deliverables are met on time and within budget.
• Drive risk assessment consistency ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle.
• Participate in team meetings and workshops as required.
• Provide expert support with deviation or non-conformance management.
• Review and approve documentation as necessary ensuring project documentation is always right first time.
• Support internal or external inspections as required and provide subject matter expertise on qualification activities.
• Stay current with changes in regulatory requirements and industry best practices.

• Bachelor’s degree in engineering, Science, Life Sciences, or related field.
• 10+ Years’ experience in commissioning, qualification, and validation within the pharmaceutical, biotechnology, or related regulated industry.
• Strong knowledge of relevant regulations (FDA, GMP, ICH Q8/Q9/Q10) and industry standards.
• Experience leading cross-functional project teams and proven ability to drive and motivate a team is essential.
• Must have previous experience in a C&Q project management role.
• Knowledge of a wide range of C&Q disciplines including CSV (Computer System Validation), Utility, Facility & Equipment qualifications.
• Excellent written and verbal communication skills.
• Expert understanding of risk-based commissioning and qualification in line with ISPE C&Q (2019)
• Self-directed, self-motivated with an ability to represent the C&Q function in a high paced project environment
• Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays. 

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 thisposting 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 Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s 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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html