Cleaning Validation & Commissioning Specialist

AbbVie•North Chicago, IL

2d•$84,500 - $162,000

About The Position

An engineering professional that 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, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

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

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, support training of staff/operators on new equipment or processes, reviewing new or modified product documentation to ensure compatibility with qualified equipment/process and implementing changes as necessary
Leads Execution of Risk Management. including, periodic review and update per the Validation Master Plan, interface 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 scale. 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 the 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.