This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Client’s Thousand Oaks (ATO). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
Responsibilities:
Be individually accountable for the verification deliverables
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
Assist in development and review of User Requirements Specifications (URS).
Suggest design modifications to address risks and design in quality and safety.
Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout
Ensure safety during commissioning, validation, maintenance and manufacturing activities
Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Responsible for equipment troubleshooting in a timely manner.
Identifying reliability improvements for assigned equipment to improve equipment uptime.
Skills:
Problem solving and applied engineering.
Basic technical report writing and presentations
Verbal communication
Personal Organization
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy (Maximo, Track wise, E-Builder, PCS, Client and QEMS)
Must Have Skill Sets:
Ideally would have 2 - 5 years pharmaceutical industry background.
Bachelor’s degree Engineering and manufacturing background
Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
Teamwork experience
Pharmaceutical equipment management background
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
IT Services and IT Consulting
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