Description

Responsible for ensuring all laboratory instrumentation and associated software systems are in a state of regulatory compliance and readiness.  Maintain system for tracking equipment on site, and coordinate with vendors or internal resources to perform maintenance, calibration, and repairs on all analytical laboratory equipment.   

• Schedule and execute on-time IQ/OQ, calibration, routine maintenance, and re-calibration activities of pharmaceutical laboratory equipment in compliance with applicable SOPs minimizing impact to laboratory activities and manufacturing. Proactively communicate timelines. Maintain strict timelines while demonstrating flexibility in day-to-day activities and scheduling. Update the calibration schedule and equipment lists as work is performed.

• Strong ability to effectively manage and organize multiple tasks & responsibilities with simultaneous competing priorities in a high-paced environment.
• Administer users and conduct standard configuration within instrument software, including rebooting of LAC/E boxes.
• Assist with change control process as needed.
• Knowledge of and ability to perform minor chromatography troubleshooting.

• Maintain inventory to ensure adequate parts and supplies are in stock. Complete requisitions for equipment and parts as needed.

• Act as an escort for the approved vendors performing required external calibration and review calibration notebooks per applicable SOPs/procedures.

• Promote and provide excellent customer service and support. Maintain a positive relationship with all the members of CHP while promoting a positive team environment.
• Comply with Good Manufacturing Practices (GMP) and follow company policies and safety regulations.

Promote teamwork by working collaboratively with colleagues for the good of the business overall.

Proven capability to focus on delivering excellent results.

Proven ability to recognize opportunities / issues and apply analytical and creative thinking to maximize performance.

Strong customer service focus and ability to effectively interact with all levels of employees.

• BA/BS in chemistry, life sciences, metrology, or related engineering or science discipline or equivalent (experience + education) plus minimum 5 years of experience in FDA-regulated pharmaceutical manufacturing industry, with minimum 2 years hands-on laboratory experience in equipment calibration/qualification.
• Experience in Quality System/Pharmaceuticals, planning maintenance &/or calibration activities, and investigating OOT results is a plus.

• Some knowledge of Agilent ChemStation/Open Lab and Waters Empower

• Basic knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.

• Basic knowledge and experience in the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems.

• Basic knowledge of metrology practices and theories and understanding of industrial instrumentation and measurement principals.

• Good troubleshooting and problem-solving skills; ability to analyze and diagnose instrument failures rapidly and effectively.

• Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

• Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

• Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.

PI285795189