Instrumentation and Calibration Engineer

PPL Pharma Solutions Riverview•Riverview, MI

2d•Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. The Instrumentation and Calibration Engineer has the responsibility for ensuring the site’s production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management.

Requirements

Bachelor’s degree in an engineering discipline and 3 years of experience in a related or similar field, or Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.
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 used at an 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 and come up with innovative solutions to complex problems.
Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root 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.
Time management: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing.
A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.
Safety-conscious: the ability to identify potential hazards and take the necessary steps to mitigate them.
Knowledge of CMMS system and functions
Knowledge of the regulations and their application to instruments that gather GMP data in a production environment.

Nice To Haves

Preferred experience in the Agile Project Management System.

Responsibilities

Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing 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 on production instruments, such as temperature sensors (RTDs/ resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters.
Support root cause investigations to a detailed level for an FDA regulated/cGMP environment, and translate 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 supplier operating and maintenance manuals, installation and operational qualification.
Translate data from Root Cause Centered Maintenance (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 strategic objectives in 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 design thru implementation.
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