Engineer, Biotech

3 Key Consulting

Job Location:

Thousand Oaks, CA - USA

Hourly Salary: $ 40 - 44

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 long-term 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 (risk-based 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 execution 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 science-related 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 risk-based verification on major GMP process equipment / automation projects including validation protocol development and execution

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

Regards

3KC Talent Acquisition Team

Required Experience:

Job Title:Engineer BiotechLocation:Thousand Oaks CA.Employment Type: ContractDuration:12 months with possible extensions or conversion to FTERate: $40 - $44/hourPosting Date:05/22/2024.Summary:The senior engineer works in partnership with the automation maintenance project management corporate engin...

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 (risk-based 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 execution and closeout
Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Bachelors degree in engineering or another science-related 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 risk-based verification on major GMP process equipment / automation projects including validation protocol development and execution