Job Title:Engineer Biotech Location:Thousand Oaks CA. Employment Type: Contract Duration:12 months with possible extensions or conversion to FTE Rate: $40 $44/hour Posting Date:05/22/2024.
Summary: The senior engineer works in partnership with the automation maintenance project management corporate engineering and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and longterm strategy.
Responsibilities:
Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
Suggest design modifications to address risks and design in quality and safety.
Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (riskbased approach).
Oversee development of validation protocols in line with CQP Automation Systems Delivery SOPs and cGMP standards.
Recommend evaluate and manage performance of contract resources
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between engineering and quality assurance during project planning and closeout
Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation
Basic Qualifications: Doctorate degree OR Masters degree & 3 years of engineering and/or manufacturing experience OR Bachelors degree & 5 years of engineering and/or manufacturing experience
Preferred Qualifications / Skills / Experience
Bachelors degree in engineering or another sciencerelated field
7 years of relevant work experience with 5 years experience in operations/manufacturing environment
Direct experience with regulated environments (FDA OSHA EPA etc.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes clean utilities facilities instruments and equipment
Experience implementing riskbased verification on major GMP process equipment / automation projects including validation protocol development and
Interview Process: One phone and one virtual panel interview.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.