Manufacturing Engineer
Warsaw, IN
1 Year Contract
Principal Duties and Responsibilities:
Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipment
Support a wide variety of Equipment qualifications including CNC machines
Guide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validation
Create change requests in windchill to support equipment moves
Execute 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 abilities
Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
Experience writing and executing validation protocols and reports, including IQ/OQ/PQ documentation
Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
Good 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 skills
Ability to independently develop and execute on project plans.
Demonstrated ability to take initiative and provide recommendations on process, procedure and training.
Education/Experience Requirements
B.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing.
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