Sr. Validation Specialist
Rochester, NY Posted: 5/26/2021
The Senior Validation Specialist manages complex validation projects or multiple validation project activities under limited supervision, and performs assigned validation tasks such as validation product annual reviews and validated utilities re-certifications.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Executed Protocols that Ensure Qualified Systems & Equipment
- Develops and executes equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities supporting these operations.
- Ensures appropriate validation activities are included in site or team project plans: including tasks, manpower requirements, and duration.
- Performs proper and timely sampling of in-process/intermediate products and surface swabbing for testing as outlined by validation/qualification protocols.
- Analyzes data, utilizing appropriate statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
- Gathers photocopies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw materials certificates of analysis.
- Investigates and assists in resolving deviations/ exceptions from the predefined acceptance criteria.
- Draws conclusions from data, observations, deviation/exception and investigation as to whether a process is considered valid.
- Interacts with and coordinates compliance efforts with other departments including, but not limited to: Operations, Engineering, QA, QC laboratories and Tech Services to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
Validation Protocols & Documentation
- Writes validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
- Writes summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/ qualification procedures and policies.
- Maintains protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
- Ensures protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are maintained according to procedure.
- Keeps abreast of industry current practices, and modifies SOPs and validation practices to align with industry.
- Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
- Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done.
- Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
- Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
- Ensures stakeholders are appropriately trained on the process and any process changes.
- Bachelor’s Degree in Science or Engineering Discipline preferred.
- Associates degree may be considered with relevant experience.
- Stay abreast of changes in cGMP trends for validation and industry standards.
- Effectively communicate, both written and oral, validation requirements and policies to a diverse group of technical personnel.
- Ability to manage multiple projects in different phases of project completion, at varying times.
- Motivate and challenge internal and external personnel to maintain a high level of customer service and system compliance.
- Ability to effectively change and adapt project scope creep and change in timelines.
- Understanding of FDA requirements for validation.
- The ability to analyze and interpret data.
- In depth knowledge of manufacturing equipment, utilities and processes.
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