Validation Specialist

Unifin SAS • Rochester, NY

13d

About The Position

Reporting to the Director of Quality,
JOB SUMMARY:

Manages 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.

Requirements

• Bachelor’s Degree in Science or Engineering Discipline preferred. Associates degrees may be considered with relevant experience.
• BS degree with 0-2 years. Co-op/ internships preferred. 3+ years’ relevant experience in validation, GMP or regulated environment and Associates degree will be considered.
• 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 distinct phases of project completion, at varying times.
• Motivate and challenge internal and external personnel to maintain an elevated 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.

Responsibilities

• 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, work force 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.
• 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.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level