Senior Equipment Specialist

Company Description

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Our high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.

Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.  Join us and help us achieve our mission of Science for a Safer World! 

Our kit and component manufacturing sites are situated across the US (Middleton, Petaluma, and  Novato) and Europe (Berlin and Lystrup) and are underpinned by either ISO 13485 or ISO 9001 compliance. These capabilities support a wide portfolio of off-the-shelf components and kits critical to NGS workflows including magnetic beads, oligos, enzymes, and library prep kits. Additionally, our primary manufacturing capabilities enable customization and bulk (OEM) manufacture of reagents such as key NGS enzymes for high volume applications.

Job Description

The Senior Equipment Specialist ensures that the site’s laboratory and production processing equipment are qualified, available, and maintained for their intended company uses in a cost-effective manner and in compliance with appropriate quality and safety standards. The Specialist supports departmental management by leading the site’s equipment procurement, qualification, calibration and monitoring program. This individual ensures appropriate and thorough asset management, including preventive maintenance and repair of existing equipment.

• In partnership with Operations and Facilities Manager and other departmental leaders, develop, implement, maintain, and improve policies, procedures, and budgets for the management of the site’s production and analytical equipment
• Provide effective management of the processes for equipment procurement, qualification, calibration, monitoring, and asset management, including preventive maintenance and repair of existing equipment
• Maintain an effective environmental monitoring system and alarm response program for key assets
• Assist with capital plan development, budget management and cost controls, and the management of suppliers, contractors, and associated quality system documentation; recommend cost savings opportunities as a part of capital and budget planning
• Review and approve contracts with LGC’s critical suppliers for equipment
• Determine and coordinate equipment training requirements in cooperation with safety officers and departmental management
• Partner with QA to approve production deviations, support complaint investigations and the disposition of nonconforming items involving production or analytical equipment performance
• Review and approve acceptance criteria for equipment qualifications and process validations
• Participate in corrective action and preventive action root cause investigations, plans, and effectiveness checks as directed
• Identify equipment capability and process improvement opportunities based on first-hand observation and data review; independently execute improvements where relevant
• Support Senior Facilities Manager in providing planning and guidance to site leadership on capital and equipment planning
• Conscientiously learn and diligently follow the requirements of the site’s ISO 13485 quality management system; ensure equipment complies with appropriate quality, health, safety, and security practices

Qualifications

Minimum Qualifications:

• High school diploma with 8+ years of progressive experience in equipment maintenance and/or procurement within a manufacturing organization
• Demonstrated mechanical aptitude required in order to contribute to successful troubleshooting and repair/replace decisions on faulty electrical, mechanical, and electronic equipment
• Working knowledge of quality system requirements for infrastructure, work environment, document control, and quality records (either ISO 9001; ISO 13485; 21 CFR 820; or 21 CFR 210) required
• Expert knowledge of metrology required, as evidenced by the