Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
ROLE SUMMARY
The Analytical Development Equipment Specialist is a very exciting position within the Product Technology/Product Development organization at Meridian Medical Technologies. The Specialist is responsible for the equipment installation and, qualification in ADL and QC Chemistry and equipment verification in ADL. This position works in collaboration with Engineering, Automation, Validation, Pharmaceutical & Product Technology, Regulatory, Quality Assurance and Data Integrity. The Equipment Coordinator partners with area owners and laboratory SMEs to ensure there is a robust dialog to efficiently release new laboratory instruments and decommission of obsolete laboratory instruments.
ROLE RESPONSIBILITIES

• Coordinates the analytical instrument installation for MMT QC Chemistry and Analytical Development laboratories.
• Coordinates Analytical Development equipment verification and maintenance processes to minimize equipment out of order.
• Prepare Change Management documents to create implementation plan for new systems and firmware and hardware updates.
• Decommissions ADL obsolete equipment.
• Coordinates training on laboratory equipment.
• Administers standalone laboratory computer applications.
• Provides technical support for the selection and evaluation of new equipment.

BASIC QUALIFICATIONS

• 4 Year degree (BS or BA) in Chemistry, Biology or other related science or engineering field.
• 5 Year experience in a GMP laboratory.
• Experience with Change Management, GMP compliance, Excel:
• Physical/Mental Requirements:
• Standard work environment. Position requires routine onsite attendance.
• Must have the ability to multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. These activities may not be time bound to core hours or presence at the site.