Meridian is a fully integrated life sciences company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.
Responsible for day to day performance and documentation of validation studies assigned to the Validations Department. Design and execute of equipment qualifications (IQ, OQ, PQ), test method validation, raw material qualifications, specification validations (characterization studies), and process validations (PPQ). Perform and oversee validation activities in Production Departments when appropriate, and secondarily provide troubleshooting, preventative maintenance on equipment, and problem-solving support for production related problems.
Project Management Activities Lead project teams for validation projects Develop and manage timelines for IQ/OQ/PQ activities for production equipment installation and validation.Validation Activities Write and execute validation protocols for equipment, facilities, software and processes (e.g. IQ, OQ, PQ). Prioritize plan and schedule validation studies. Arrange and coordinate the participation of other departments in validations. Assure that required supplies are present and the equipment used for validations is certified, calibrated and documented. Collect and analyze validation data. Write and submit validation reports for approval. Lead project teams for validation projects Support other engineersOperations Support Support the validation efforts of other departments. Help identify and work with alternate vendors. Understand and assure conformance to GMPs, GLPs, safety SOPs and sound scientific principles. Supply troubleshooting support to help identify the causes of product/production related problems. Maintain complete and accurate documentation of troubleshooting and validation activities. Other duties as assigned.
Education/Experience: Bachelors degree in Chemistry, Biochemistry, Microbiology or Engineering (Chemical, Mechanical, Biomedical) or a closely related scientific discipline is required. Prior experience in a FDA/GMP regulated industry (pharmaceutical, medical devices or food) is recommended. Prior experience in writing and executing test methods, validation studies, related documents and/or SOPs is recommended. Knowledge of control systems and process controls is also desirable. Skills, Specialized Knowledge and Abilities: Understanding of manufacturing equipment and instruments. Ability to read, understand and follow all company SOPs and guidelines. Familiarity with good scientific principles. Excellent documentation skills as required by cGMPs on a timely basis. Strong technical writing skills. Excellent analyzing, problem solving and troubleshooting skills. Excellent interpersonal, organizational, written and oral communication skills. Ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting. Must be a self-starter, able to prioritize and handle multiple tasks and ability to meeting strict deadlines and perform under pressure in a fast-paced work environment. Familiar with laboratory safety practices. Computer proficiency (Word, Excel), Project and SPC knowledge. Ability to maintain regular attendance and punctuality requirements. Ability to have flexibility to work hours outside the normal work day (start early, stay late or weekends) to support department activities and coordinate with production schedules and validation execution times. Requirements (Physical, Mental, Environmental Demands): Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility. Must be able to lift 40 pounds routinely throughout the course of a work day. Must be able to wear personal protective equipment (latex or nitrile gloves, face shield/safety glasses, hairnets, shoe coverings, etc.). Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories. Ability to stand for long periods of time, stoop, reach, push and pull equipment throughout the course of the work shift. Ability to work on PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day May be required to sit for long periods of time through the course of the work shift. Must be able to analyze and interpret data. Must be able to concentrate and problem solve routinely throughout the course of the work shift. Must be able to differentiate colors in product.We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.