PLS Equipment Specialist II

About the role

Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. This full-time, onsite Equipment Specialist II position is located in Oakdale, MN. The role is responsible for executing and overseeing the maintenance, repair, and qualification of laboratory instrumentation, hardware, and software, and for providing feedback and guidance using advanced professional and technical knowledge of mechanical, scientific, or related instrumentation and software.

Responsibilities

• Perform advanced diagnostics, maintenance, qualification, troubleshooting, and repairs of laboratory equipment, specifically temperature-controlled and/or pressurized units
• Coordinate and oversee vendor management of laboratory equipment to support onboarding, inventory, repair, and decommissioning of equipment, as needed
• Provide on-call support during non-standard business hours to address critical equipment excursions
• Source and ensure current inventory of consumables and repair parts for instruments as needed
• Draft and/or revise technical documentation such as SOPs, calibration procedures, qualification protocols, and other documents as needed
• Communicate with vendors, staff, and customers to provide advanced support, explain troubleshooting, and provide solutions
• Provide fundamental analysis and interpretation and counsel to staff, management, and functional leaders regarding equipment policies, programs, and practices involving standard operations
• Ensure accuracy of equipment, actions, procedures, and operational databases, reports, and related details through audits, queries, and reviews; work with team to resolve discrepancies to ensure compliance with quality system

Qualifications

Education and Experience

Bachelor's degree in chemistry, biochemistry, or a closely related field; AND two to four (2-4) years of experience; OR an equivalent combination of education, training, and experience.

Required Knowledge

• Advanced knowledge of laboratory and analytical instrumentation
• Advanced knowledge of metrology standards
• Principles, practices, and techniques to diagnose, troubleshoot, and solve problems
• Advanced knowledge in testing tools, instruments, and calibration
• Comprehensive understanding of the administration and oversight of area programs, policies, and procedures
• Methods to resolve area problems, questions, and concerns
• Comprehensive understanding of applicable area laws, codes, and regulations
• Expert understanding of comprehensive testing tools, equipment, and calibration
• Computer applications and systems related to the work
• Principles and practices to serving as an effective project team member
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations
• Correct business English, including spelling, grammar, and punctuation

Required Skills

• Performing advanced instrumentation troubleshooting
• Administering instrument, mechanical, electrical, and software-based functions
• Serving as a leader in the design, development, and management of projects
• Operating in both a team and individual contributor environment, as well as project leader