Lab Equipment and Facilities Specialist
Pharmaron

Lab Equipment and Facilities Specialist

ROLE SUMMARY

The Lab Equipment and Facilities Specialist will join the team to support laboratory equipment qualification projects and the Metrology program at the Pharmaron Woburn, MA site. Lab Equipment and Facilities Specialist should be familiar with the validated state of equipment, instruments, facility, and systems supporting current Good Practices (cGxP) that remain compliant with corporate policies and regulatory requirements.

ROLE RESPONSIBILITIES

• Ensure Life Cycle Asset Maintenance by facilitating all critical equipment calibration and preventative maintenance is completed per schedule.
• Assure all laboratory equipment is in proper operating condition and is appropriately labeled with current status.
• Coordinate outside vendor visits for all vendor performed calibration and maintenance activities.
• Coordinate outside vendor visits for facilities maintenance and upkeep.
• Champion Change Control processes for commissioning and decommissioning of equipment
• Collaborate with User Department to determine equipment qualification requirements and authoring qualification documents.
• Perform internal qualifications, calibrations, verifications and preventative maintenance.
• Perform internal facility maintenance and upkeep.
• Maintain the equipment records in Blue Mountain RAM.
• Manage and maintain equipment history files and ensure proper documentation of all work performed on equipment or systems, as applicable
• Maintain correct levels of spare parts for critical equipment to support department activities
• Provide support and troubleshooting of equipment necessary to meet all customer requirements including identifying issues or causes of failures
• Generate and revise SOPs as required in support of equipment and facility operation.
• Participate in Client and Regulatory inspections, as required.
• Support management needs in other related duties, as required.

BASIC QUALIFICATIONS

• Associate Degree in a science or engineering discipline is desired.
• 1+ years of experience in Lab equipment maintenance validation in cGxP pharmaceutical or laboratory environment required.
• Knowledge of cGxP regulations/guidance's (21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry is preferred.
• Excellent organizational and communication skills, ability to work in the team environment

PHYSICAL/MENTAL REQUIREMENTS

• Detail-oriented • Excellent communication skills, both oral and written • Excellent organizational skills • The candidate must be able to collaborate effectively with multidisciplinary project teams. • The candidate must be able to handle a diverse and dynamic workload. • Requires limited supervision for routine assignments and recognizes when management involvement is necessary. • Strong problem-solving skills are a plus.

Excellent computer skills are required and you must be proficient in Microsoft Office including Word, Excel (formulas, graphs, and charts), and PowerPoint.

Ability to lift up to 50 pounds

***Position is ONSITE***

This job has expired.