Cleaning Validation & Commissioning Specialist

About the role

A cleaning validation and commissioning specialist works with project owners, subject designers/engineers, and other project team members to plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, product, and processes in line with project, operations, and quality objectives. The main objective is to establish evaluation, testing, and documentation for risk management, commissioning, and validation, applying product and regulatory requirements to ensure robust, high-quality products.

Responsibilities

• Develop and execute commissioning, qualification, and validation test protocols.
• Able to support broader aspects of projects at times, including: project leadership, developing operational procedures, supporting training of staff/operators on new equipment or processes, reviewing new or modified product documentation to ensure compatibility with qualified equipment/processes, and implementing changes as necessary.
• Leads Execution of Risk Management, including periodic review and update per the Validation Master Plan, interfacing with best practices, establishing team & work practices including overall program, ccRA.
• Understands risk management principles, can find and review documentation, understands controls, impact of change, trace controls, and can estimate ratings using appropriate scales. Timely. Demonstrated success in FMEA authorization/facilitation.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
• Responsible for the coordination and execution of the sampling related to cleaning validation following the established procedures and applicable protocols. Document the results obtained and completion of cleaning validation summary reports accurately as required.
• Generate and process change requests per the applicable procedures.
• Lead the implementation of special projects related to cleaning validation area.
• Prepare area reports and presentations as applicable.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EH&S) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Requirements

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
• Experience in the development of commissioning, qualification, validation, and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality, or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred.
• A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred.
• Ability to supervise junior or contract team members (prior supervisory experience preferred).
• Ability to manage complex projects and multiple projects (5+) simultaneously.

Qualifications

• Must be able to pass a drug screen and background check.

Skills

• Strong knowledge of risk management principles and FMEA.
• Experience in commissioning, qualification, and validation of equipment, facilities, utilities, product, and processes.
• Excellent organizational and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong attention to detail and accuracy.
• Proficient in Microsoft Office Suite.

Benefits

AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) to eligible employees.

Pay

$84,500 - $162,000 USD

Schedule

Full-time, On-site