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Validation Specialist

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Senior Manager, Engineering,

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.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Executed Protocols that Ensure Qualified Systems & Equipment (40%)

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.

Validation Protocols & Documentation (40%)

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.

Process Improvements (20%)

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.

Your profile

EDUCATION & EXPERIENCE:

Bachelor’s Degree in Science or Engineering Discipline preferred. Associates degree 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.

Compensation range

58,000.00 - 70,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!