Commissioning and Validation support of the cleaning, equipment and process related to biopharmaceutical Manufacturing operations.
- Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
- 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.
- Support of cleaning development including bench-scale process simulation testing, CIP cycle development, visual and surface analysis and assessment of equipment cleanability.
- BS or MS degree in Science or Engineering
- 2-5 Years relevant Industry experience
- The temporary Validation Engineer II will 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 good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) 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 validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) 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.
- Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred.
- ASQ Certification or equivalent is preferred.