What are the responsibilities and job description for the Equipment Qualification Expert (PM) position at Tech Observer?
Job Description
Job Title: Equipment Qualification Expert (PM)
Location: Indianapolis, IN
Duration: 06 months contract with possible extension
Job Details
Writing equipment qualification and validation master documents e.g. User Requirements, Design Specifications, Configuration Specifications, Software Specifications etc. Generating equipment commissioning and qualification protocols including SAT, IQ, OQ & PQs preferably in paperless system (KNEAT). Execution of qualification and validation test scripts in line with the qualification/validation plan, protocols using paperless qualification software, Kneat. Following client procedures of qualification/validation as well as good documentation practices. Recording excursions / deviations from the protocol (if any) and performing root cause analysis to determine root cause and resolutions, Working with client associates in engineering, quality and project management to timely resolve all issues and closed documents on time. Writing validation summary reports and release of systems to next step. Working with equipment vendors and other technical support to complete qualification work seamlessly and timely.
Major Accountabilities
Drafting, reviewing and pre-approval of protocols in a timely manner. Adherence to client GDP (Good Documentation Practices), Data Integrity and other relevant SOPs. Adherence to overall project schedule. Ensure all commissioning and qualification protocols are compliant to client quality manual and site procedures. Fosters an environment that enables the most efficient and effective work processes to achieve project objectives and milestones. Implementation of and compliance with all the guidelines and requirements for safe work, environment protection and property protection.
Experience
6 years project management experience, of this, 2 years within similar role and complexity; experience in Health Care / Pharma Industry preferred.
Strong planning capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, working in a matrix organization). Strong proficiency in Microsoft Excel, PowerPoint, and MS Project.
Education
Degree in Science and Certification in Project Management (preferred).
Extensive project management experience may substitute the need for a degree.
