Lead Commissioning, Qualification and Validation support of Medical Device Company
- Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
- In depth understanding of the governing standards for medical device sector.
- Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements and acceptance criteria.
- Own and Manage Change Controls to allow for the ongoing maintenance and optimization of Validated systems.
- Generation, execution and closeout of Commissioning and Validation documentation, including test plans, procedures and protocols.
- Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc.
- BS or MS degree in Science or Engineering
- 5-10 Years relevant Industry experience
- Provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.
- Communicates current and applicable good manufacturing practices (GMP) and to business partners.
- Executes functions needed to support change control activities and document management requirements.
- Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
- Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
- Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability.
- Writes/revises or reviews /approves a variety of validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.
Key Requirements and Technology Experience
- A minimum of a Bachelor’s degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, and/or related discipline is required. Master’s degree a plus.
- A strong background in medical device validation is required.
- Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.
- Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.
- Must be analytical, detail-oriented and able to interact with individuals of all levels.