Senior Validation Engineer

Rochester Senior Validation Engineer

The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring.

The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are adhered to. This role will assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.

What You Will Achieve

In this role, you will:

• Support the validation/qualification of manufacturing equipment, facility and critical utility systems.
• Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles
• Support the validation/qualification of laboratory equipment
• Develop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents
• Develop/Author validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification
• Work cross functionally with multiple departments to schedule and complete all required activities
• Support corrective actions including investigating and resolving deviations as relevant to validation
• Support technical training on process and technology as required by the project
• Support audit preparation and defend areas of Validation responsibility
• Carry out process capability analysis on all commercial processes on a periodic basis. Identify areas for improvement where process capability is deemed to be unacceptable
• Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
• Review site change controls to ensure the validated state of a process is not impacted by a proposed change
• Lead the implementation of projects to reduce process risk, optimize plant and process productivity
• Will required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade
  
  D)

Here Is What You Need (Basic Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with sterile products and medical devices
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other colleagues
• Experience in regulatory audits and compliance
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

• This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin.
• Must be able to aseptically gown.

Able to lift 25-30 lbs.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Non-standard work schedule at times may be required to support product release, including weekend, second shift, night shift work / call for process decisions.
• Minimal travel for training/seminars.

Relocation support available Work Location Assignment:
On…