Cleaning Validation & Commissioning Specialist
About The Position
An engineering professional who works with project owners, subject designers and engineers, and other project team members to plan and complete commissioning, qualification, and validation tasks for new and modified equipment, facilities, utilities, products, and processes. The role applies product and regulatory requirements and risk management to establish evaluations, testing, and documentation that support robust, high-quality products and meet project, operations, and quality objectives. Responsibilities and performance are commensurate with grade level, and the position also supports optimization of systems related to its area of responsibility. The specialist develops and executes commissioning, qualification, and validation protocols; leads risk management activities; coordinates cleaning-validation sampling and documentation; and may support broader project activities, supervise contract validation resources, and lead special cleaning-validation projects. The role provides assistance to operations in accordance with environmental management and occupational health and safety systems, and promotes continuous improvement.
Requirements
- Bachelor’s degree in engineering, science, or a closely related discipline, or equivalent technical experience plus demonstrated competence.
- Experience developing commissioning, qualification, validation, and risk-management deliverables, including specifications and testing protocols that can withstand regulatory scrutiny.
- Strong interpersonal, communication, and negotiation skills, with demonstrated ability to work in a team environment.
- Ability to supervise junior or contract team members.
- Ability to manage complex projects and five or more projects simultaneously.
Nice To Haves
- Three or more years of significant engineering and/or operational experience is desired.
- Six or more years of overall experience in manufacturing, quality, or engineering, including experience with four major validation subjects (for example, computer, equipment, cleaning, or process validation), preferred.
- Technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries.
- Knowledge of quality and compliance management and regulations and standards affecting API, bulk drug, or finished-goods manufacturing.
- Prior supervisory experience.
Responsibilities
- Develop and execute commissioning, qualification, and validation test protocols.
- Support broader project activities, which may include project leadership, developing operational procedures, training staff or operators on new equipment or processes, and reviewing product documentation for compatibility with qualified equipment or processes and implementing changes as needed.
- Lead risk management execution, including periodic review and updates per the Validation Master Plan, alignment with best practices, and establishment of teams, work practices, and the overall program, including ccRA.
- Apply risk management principles; find and review documentation; understand controls, change impacts, and trace controls; estimate ratings using the appropriate scale; and facilitate and authorize FMEAs in a timely manner.
- May supervise contract validation resources to ensure timely completion of activities in the assigned area.
- Coordinate and execute cleaning-validation sampling in accordance with established procedures and applicable protocols.
- Accurately document cleaning-validation results and complete summary reports as required.
- Generate and process change requests according to applicable procedures.
- Lead implementation of special projects related to cleaning validation.
- Prepare area reports and presentations as applicable.
- Assist operations in accordance with environmental management and EH&S systems and promote continuous improvement.
- Comply with applicable EHS procedures and policies, including incident reporting, PPE use, waste management and disposal, and other programs relevant to the position.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
