Manufacturing Engineer

Job Description

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.