Senior Validation Engineer

Responsibilities:

Ensure a safe and quality working environment through training, awareness, and compliance with safety guidelines and SOPs.

Ensure the maintenance of their department, premises, and equipment.

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Provide validation manager/supervisor backup and site support.

Independently plan, perform, and document validation activities (IQ, OQ, PV, PQ) for new and existing equipment, facilities and utilities in pharmaceutical manufacturing, manufacturing support and QC environments.

Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, lab personnel and quality assurance staff members.

Track and communicate progress of work against milestones.

Write validation plans, protocols, traceability matrices, FMEAs and final report summaries.

Assure full compliance of personnel training, method validation and process qualification related to validation activities.

Collect and review validation data and generate exception reports as needed.

Conduct process and equipment assessments to ensure compliance with FDA regulations.

Conduct SOP reviews and ensure alignment with corporate policies and procedures.

Program and operate a Kaye Validator 2000 and execute temperature mapping.

Generate and review Change Control documents, site validation documents, and site Standard Operating Procedures.

Coordinate validation personnel on assigned projects and ensure tasks are completed accurately and on schedule.

Maintain current knowledge of federal and state regulations regarding validation and camp's and proactively champion validation initiatives to meet same.

Work with Document Control function to maintain adequate records such as systems and equipment drawings, specifications, protocols, schedules, validation records and reports, etc., as required to establish control of all processes, systems, and equipment.

Assist in training and development of validation personnel.

Perform periodic SOP revisions to assure alignment with corporate and regulatory requirements.

Experience:

Bachelor's degree in engineering or related life sciences required. Work experience is considered in lieu of a degree.

5 or more years of relevant experience required.

Working knowledge of global camp's (to include EU standards) and finished pharmaceutical manufacturing requirements.

Subject matter expert (proven) in three or more of the following areas: lyophilizes, autoclaves, VHP, isolators, computer systems, cleaning, process, automated fillers, stopper processors, CIP/SIP, dehydrogenation ovens, thermal units, WFI and Clean Steam systems or HVAC.

Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment.

Strong communication, organization and time management skills are necessary.

Strong problem solving, decision making, verbal and written communications skills.

Proficient in use of Microsoft suite of products.

Frequent partnering with Production, Engineering and QC departments.

Day-to-day activities include office work as well as hands-on validation activities on the manufacturing floor.