About the role
Engineering
Full-Time
Effectively manages the design and installation of pharmaceutical processes in a cGMP environment. Develops and implements solutions to ensure continued and efficient equipment operations. Participates in process improvement initiatives related to equipment and processes, and efficiently manages IQ, OQ, PQ, and validation activities.
Job Responsibilities
Oversees the installation, operation and maintenance of production equipment *
Develops and leads an Engineering team of various skill levels *
Investigates equipment failures and difficult-to-diagnose faulty operations and makes recommendations for improvement *
Trains other employees on proper use and setup of machines and equipment *
Complies with established standard operating procedures, cGMP quality standards and regulatory procedures *
Creates and updates SOPs (Standard Operating Procedures) *
Creates and updates equipment and facility drawings *
Determines how key quality attributes can be influenced by processing and can be controlled *
Assists with new equipment installations *
Writes and executes IQ, OQ, and PQs *
Writes and executes validations *
Sets up calibrations *
Sets up PMs (Preventive Maintenance) *
Precisely follows work orders and specifications *
Adheres to all plant safety policies and procedures *
Effectively communicates with other production employees and with all levels of management *
Promotes a positive can-do attitude *
Collaborates in cross-functional teams *
Flexible and open minded to suggestions from others; keen vision for continuous improvement *
Consistently follows all company policies & procedures *
Performs other duties as requested
* Essential job function
Physical Requirements
Stands, walks 50% of the time
Repeatedly lifts or pushes a cart with 30–70 lbs
Qualifications
Bachelor’s Degree in Engineering *
5+ years of experience in the Engineering, Operations and Production areas of a pharmaceutical GMP production environment *
5+ years in a management role leading an Engineering team *
