Commissioning and Qualification Manager

AbbVie•Barceloneta, PR

9h•Onsite

About The Position

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.

Requirements

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.

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.