Validation Engineer I

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. Utilizing a variety of methods, these products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, urinary and respiratory infections.

We are currently looking for a Validation Engineer I with Process Engineering experience. Responsible for day to day performance and documentation of validation studies assigned to OCS Technical Validations. Execution and planning of manufacturing equipment protocols (IQ, OQ, PQ), test method validation, raw material qualifications, specification validations (characterization studies), and process validations (PPQ). Will support the validation activities for the R&D and Manufacturing Departments, provide troubleshooting and problem-solving support for production related problems and assist Process Engineering in the design and selection of equipment and production lines.

Duties
• Write and execute validation protocols for equipment, facilities, and processes.
• Assist in training Technical Validations staff as needed.
• Prioritize, plan, and schedule validation studies. Collect and analyze validation data. • Arrange and coordinate the participation of other departments in validation activities.
• Assist in the identification and qualification of 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.
• Support Facilities and Manufacturing in the justification of capital expenditures and the selection and qualification of new equipment.
• Provide support to R&D for establishing Design Control and critical process parameters.

Qualifications Required:

Experience and Education:
BS or MS degree in Engineering (Chemical, Mechanical, Biomedical or Industrial) is or a closely related scientific discipline with suitable experience is required.
One to three years of process validation experience in a FDA/GMP regulated industry (pharmaceutical, medical devices or food).
Prior experience in writing and executing test methods, validation studies, related documents and/or SOPs required.
Experience in equipment design, line layout, manufacturing automation and knowledge of control systems a plus


Skills and Abilities:
• Understanding of manufacturing equip. and instruments.
• Familiarity with good scientific principles.
• Good problem solving and troubleshooting skills.
• Good communication skills.
• Attention to detail
• Good organizational skills
• Strong technical writing skills.
• Able to handle multiple tasks.
• Familiar with laboratory safety practices.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.