Analytical Instrumentation Specialist

Responsibilities

• 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.
• Absorb and 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.

Qualifications/Skills

• 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.

Education, Experience & Licensing Requirements

• 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 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).
• Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.
• Sedentary work. The daily work is performed in an office setting as well as the laboratories. Walking and standing are required on a regular basis to interact with colleagues, vendors and work on equipment.
• Knowledge of working safely with chemicals required.