Pharma Instrumentation Jobs (NOW HIRING)

Keyresponsibilities.

• Support thePreventive Maintenance (PM) program through thecreation of new PMtasks, evaluation ofexisting PMs for technical relevance to current asset problems.

• Help create Standard Operating Procedures (SOPs)for equipment operation, engineering analyses, PM and calibration tasks,that adhere to FDA and cGMP requirements.

• Support the management of the calibrations onproduction instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and othertransmitters.

• Support root cause investigationsto a detailed levelrequiredforan FDA regulated/cGMPenvironment, andtranslate these root causes to effective CAPAs that mitigate equipment risk.

• Assesses and monitors equipment for reliability of operation implementing necessary improvements

• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplieroperatingand maintenance manuals,installationand operational qualification.

• Translate data from Root CauseCenteredMaintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.

• Maintain calibration records, and qualification of calibration contractor.

• Manages risk to achieve organization's strategicobjectivesin areas of environmental health and safety, asset capability, quality, and production.

• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters

• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.

• Runs process improvement projects from designthruimplementation.Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.

• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs

• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization

• Participates in and execute qualification and validation of equipment and processes

EDUCATION/EXPERIENCE.

• Bachelor's degree in an engineering disciplineand 3 years of experience in a related or similar field, or

• Associate's degree inan engineeringor scientific discipline and at least 5 years of experience.

job competencies.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.

• Technical aptitude: a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems usedatan organization.

• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment.Demonstrated curiosity for how production equipment functions.

• Problem-solving: the ability to think creatively andcome up withinnovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts todetermineroot causes and create effective corrective actions.

• Communication: the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.

• Timemanagement: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.

• A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.

• An understanding of lean manufacturingprinciples, andapplying Six Sigma concepts to chemical manufacturing.

• Safety-conscious: the ability toidentifypotential hazards and take the necessary steps to mitigate them.

• Knowledge of CMMS system and functions

• Knowledge of the regulations and their applicationto instruments that gather GMP data in a production environment.