Provide validation support for site product development, process improvement, and regulatory compliance initiatives as Subject Matter Expert and corporate liaison for one or more of the following areas: Lyophilization, Sterilization - Autoclaves and Depyrogenation ovens, VHP, Isolators, Computer Systems, Cleaning, Process, Automated Fillers, Stopper Processors, CIP/SIP, WFI/Clean Steam, Thermal Units and HVAC.

Work schedule: Monday - Friday 8am - 5pm

• Ensure a safe and quality working environment through training, awareness, and compliance to 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 a 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 cGMPs 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

• Bachelor Degree in engineering or related life sciences required. Work experience is considered in lieu of degree.
• 5 or more years of relevant experience required.
• Working knowledge of global cGMPs (to include EU standards) and finished pharmaceutical manufacturing requirements.
• Subject matter expert (proven) in three or more of the following areas: lyophilizers, autoclaves, VHP, isolators, computer systems, cleaning, process, automated fillers, stopper processors, CIP/SIP, depyrogenation 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.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.