Manufacturing Engineer I

Manufacturing EngineerWarsaw, IN 1 Year ContractPrincipal Duties and Responsibilities:Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipmentSupport a wide variety of Equipment qualifications including CNC machinesGuide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validationCreate change requests in windchill to support equipment movesExecute to project plans and schedules for work activities.Communicate (written and verbal) with appropriate personnel from other departments.This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.Expected Areas of Competence i.e., knowledge, skills and abilitiesStrong knowledge of cGMP regulations, including FDA, EMA and ISO requirementsExperience writing and executing validation protocols and reports, including IQ/OQ/PQ documentationProficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systemsGood problem-solving skills through the use of quality and statistical tools.Ability to effectively work within a cross-functional team to complete critical project tasks.Demonstrates good written and verbal communication skills.Strong technical writing and documentation skillsAbility to independently develop and execute on project plans.Demonstrated ability to take initiative and provide recommendations on process, procedure and training.Education/Experience RequirementsB.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing. Aequor Inc