Job Title: Engineer Bioprocessing Systems/Equipment (JP13262 Location: Thousand Oaks CA. 91320 Business Unit: F&E Drug Product Supply Employment Type: Contract Duration: 1 year with likely extensions and/or conversion to a permanent position. Rate: $38 $42/hour W2 Posting Date: 10/14/2024. Notes: Only qualified candidates need apply. ONSITE THOUSAND OAKS Local Candidates who can report to the site Monday Friday. Flexible availability schedule is 7am 4pm need to be open to afterhours calls.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client a leading global biotechnology company.
Job Description: The qualities and characteristics we are looking for in candidates include:
Fast learner
Strong critical thinking skills
Ability to handle stress well
Technically inclined with skills in electromechanical systems.
Candidates must show an engineering mindset particularly those who use the scientific method to solve issues and provide examples of projects they have worked on.
Regarding the minimum education and experience requirements a BA in Engineering whether it be Mechanical Industrial or Electrical Engineering is suitable for this role.
As for nonnegotiables candidates must have a degree in an engineeringrelated field and must be flexible with their working hours.
Our ideal candidate:
Highly motivated individual system owner Mechanical and electrical engineering background.
Pharmaceutical industry manufacturing maintenance engineering and not operations side.
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer tunnel isolator cappers and lyophilization) filling lyophilization inspection as well as other equipment needed to support these processes such as autoclaves clean in place (CIP) systems washers clean steam water for injection etc.
The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization of our client. The groups mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report to the Senior Manager of Engineering supporting drug product supply.
Top Must Have Skill Sets:
Ability to analyze problems develop and propose engineering solutions in a scientific manner using datadriven techniques and analyses (e.g. Root Cause Analysis (RCA) Statistical Process Control (SPC) Six Sigma Predictive Maintenance etc.
Experience applying engineering principles to the design and implementation of system modifications introduction of new processes and of capital projects
Day to Day Responsibilities:
Provide system ownership for Biopharmaceutical process equipment.
Identify support and/or lead implementation of engineeringbased improvements or upgrades to the equipment or facility systems.
This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design specification and supporting the construction startup and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are working at peak capacity.
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
Monitor systems to identify performance risks and implement risk reduction strategies.
Solving issues to support and reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments implementing equipment modifications and supporting engineering runs.
Ensure regional medical activities align with practices policies and standard operating procedures.
Basic Qualifications: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Qualifications:
Bachelors degree in Chemical or Mechanical Engineering.
4 years of relevant work experience with 2 years experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP OSHA EPA etc. and familiarity with GMP quality systems/processes such as change control nonconformances corrective and preventative actions and qualifications/validation
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer tunnel isolator cappers and lyophilization) filling lyophilization inspection as well as other equipment needed to support these processes such as autoclaves clean in place (CIP) systems washers clean steam water for injection etc.
Ability to analyze problems develop and propose engineering solutions in a scientific manner using datadriven techniques and analyses (e.g. Root Cause Analysis (RCA) Statistical Process Control (SPC) Six Sigma Predictive Maintenance etc.
Experience applying engineering principles to the design and implementation of system modifications introduction of new processes and of capital projects
Red Flags: No engineering experience
Interview Process: 1 phone screening 1 interview with hiring manager 1 panel interview with coworkers
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.