Our client is looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters. Area of responsibility may consist of multiple facilities, disciplines, or clients. All work to be completed to assure minimal impact to production while complying with all safety / cGMP guidelines and company procedures.

Responsibilities:

• Directing/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner. This includes, but is not limited to, maintenance and emergency repair of all production related utilities and facility equipment that support GMP production: HVAC, HEPA certifications, and pressure cascades, water purification systems, plant and clean steam, chillers and clean gas systems.
• Additionally, the staff will need to understand room classification and gowning requirements.
• Alarms and associated subject matter expertise will be provided to triage events impact to quality or safety.
• Fundamental control system strategy and logic will need to be understood to troubleshoot and provide data trends from EMS/BMS/USC systems.
• Create, edit, or obsolete training with associated equipment systems and evaluate staff proficiency to qualification records.
• Development and maintain the current repair job plans and spares inventory control for associated equipment
• Interact with various support teams for integrated contracted partners for calibration support and outside vendors that provide contracted maintenance
• Assure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.
• Work to be completed in accordance with CFRs, cGMPs, SOPs and company policies
• Participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice

Requirements / Qualifications:

• Master’s degree OR Bachelor’s degree and 2 years of maintenance experience OR Associate’s degree and 6 years of maintenance experience OR High school diploma / GED and 8 years of maintenance experience

Preferred Qualifications:

• 2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical discipline
• 7 years combined education and experience with 4 years in an FDA (GMP) or comparable regulated environment
• Experience with RCA facilitation and participation
• Experience with RCM, TPM, or other reliability centered concepts
• Experience with installation, troubleshooting, maintenance, repair and testing of HVAC, laboratory and utilities equipment
• Advanced Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical
• Effective oral and written communication skills
• Possess a high mathematical understanding, excellent reading skills along with intermediate to advanced computer and typing skills