About this role
Duties & Responsibilities
- Manages instrument qualification, maintenance, and calibration schedules, coordinating vendor onsite visits and maintaining scheduling and status within the company CMMS
- Coordinates and supports vendor activities during onsite maintenance, calibration, qualification, and repair services
- Provides technical support to maximize system availability, system uptime, and business continuity
- Manages laboratory equipment lifecycle activities including implementation, upgrades, integrations, and retirement activities
- Coordinates resources as needed to maintain equipment in an operational and qualified state.
- Maintains system lifecycle documentation to ensure laboratory equipment remains qualified, calibrated, and fit for intended use in accordance with data integrity, company policies and procedures, and applicable regulatory requirements
- Ensures appropriate user training is established for newly implemented systems to support equipment operation and maintenance
- Performs instrument qualifications/calibrations where appropriately trained
- Performs assigned responsibilities in accordance with cGMP and GDocP standards as defined in company procedures and regulatory requirements
- Performs other related duties and assumes additional responsibilities as needed to support business and organizational initiatives
Requires Skills & Abilities
- Excellent verbal, written, and interpersonal communication skills with the ability to collaborate effectively with cross-functional teams and external vendors
- Strong organizational skills and attention to detail
- Strong time management skills with ability to manage priorities and meet deadlines in a dynamic environment
- Strong troubleshooting, analytical, and problem-solving skills
- Communicates effectively and maintains productive relationships with coworkers, vendors, and other contacts outside of the company
- Demonstrates ability to receive and provide constructive feedback
- Proficiency with Microsoft Office Suite and related applications
Education & Experience
- Bachelor’s degree in a scientific discipline or related field, with 2 years of relevant experience preferred; or
- Master’s degree in a scientific discipline or related field, with 1 year of relevant experience preferred
- Requires 1 year GMP experience
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer.
- Must be able to lift up to 25 pounds at times.
- Adheres to consistent and predictable in-person attendance.