Engineer Senior Biotech Manufacturing and Process Equipment JP12842
Engineer Senior Biotech Manufacturing and Process Equipment JP12842
Posted on :
15-03-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 44 - 48
Vacancy
1 Vacancy
Posted on :
15-03-2025
Job Description
Job Title: Engineer Senior Biotech Manufacturing and Process Equipment (JP12842
Location: West Greenwich RI. 02817
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $44 $48 / hr.
Posting Date: 6/10/2024.
3 Key Consulting is hiring! We are recruiting an Engineer Senior Biotech Manufacturing and Process Equipment for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with manufacturing process equipment at our clients Rhode Island facility. The engineer works in partnership with the maintenance Project Management Engineering Technical Lead and manufacturing to develop improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:
Top Must Have Skill Sets:
Day to Day Responsibilities:
The Engineer role will provide direct engineering technical support as follows:
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Preferred Qualifications:
Why is the Position Open
Supplement additional workload on team
Red Flags:
Interview Process:
Webex panel.
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 websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: West Greenwich RI. 02817
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $44 $48 / hr.
Posting Date: 6/10/2024.
- Notes: Fully onsite. Up to 20 domestic travel for cross site training
3 Key Consulting is hiring! We are recruiting an Engineer Senior Biotech Manufacturing and Process Equipment for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with manufacturing process equipment at our clients Rhode Island facility. The engineer works in partnership with the maintenance Project Management Engineering Technical Lead and manufacturing to develop improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:
- Identify support and/or lead implementation of engineeringbased improvements or upgrades to the equipment systems.
- This may include development of reason 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.
- Support Lean Transformation and Excellence in Operations process improvement by leading supporting and documenting improvement opportunities to reduce cost improve safety/quality or improve speed.
- Be individually accountable for the verification deliverables on key capital projects.
- Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Develop commissioning and function test plan for any equipment modifications and acquisition.
- Ensure safety during commissioning validation maintenance and manufacturing activities.
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable. Act as a liaison between Engineering and Manufacturing during project planning and closeout.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments implementing equipment modifications and supporting engineering runs.
- Ensure systems are installed and operating safely align with pertinent environmental health/safety practice rules and regulations.
- Provide ad hoc technical support and guidance for manufacturing and maintenance.
- Provide coaching and guidance to project teams and engineers on the CQP process and riskbased approaches to commissioning and verification.
- Assist in developing and maintaining metrics.
- Full time onsite support in required.
- Work schedule flexibility to support 24/7 operations requiring occasional afterhours engineering coverage as required from time to time
Top Must Have Skill Sets:
- 4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry
- Local to West Greenwich Rhode Island
- No work gap more than 3 months
- Demonstrated ability to work independently with minimal supervision
- Demonstrated to be motivated to take on new challenges
- Demonstrated ability to solve complex problems by being detail oriented and data driven
- Has shown cross functional collaboration with multidiscipline functions such as process development engineering automation maintenance and management
Day to Day Responsibilities:
The Engineer role will provide direct engineering technical support as follows:
- Identify support and/or lead implementation of engineeringbased improvements or
- upgrades to the equipment systems. This may include development of reason 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.
- Support Lean Transformation and Excellence in Operations process improvement by
- leading supporting and documenting improvement opportunities to reduce cost improve
- safety/quality or improve speed.
- Be individually accountable for the verification deliverables on key capital projects.
- Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Develop commissioning and function test plan for any equipment modifications and acquisition.
- Ensure safety during commissioning validation maintenance and manufacturing activities.
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
- Act as a liaison between Engineering and Manufacturing during project planning
- and closeout.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments
- implementing equipment modifications and supporting engineering runs.
- Ensure systems are installed and operating safely align with pertinent environmental health/safety practice rules and regulations.
- Provide ad hoc technical support and guidance for manufacturing and maintenance.
- Provide coaching and guidance to project teams and engineers on the CQP process and riskbased approaches to commissioning and verification.
- Assist in developing and maintaining metrics.
- Up to 20 domestic travel for cross site training
- Fulltime onsite support in required.
- Work schedule flexibility to support 24/7 operations requiring occasional afterhours engineering coverage as required from time to time
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Preferred Qualifications:
- Bachelors degree in chemical or other Engineering fields
- 6 years relevant work experience with 5 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 cell culture reactors chromatography filtration as well as other equipment needed to support these processes such as autoclaves clean in place (CIP) systems washers clean steam 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
- Understanding of the process of capital projects in a GMP and/or nonGMP
- Biopharmaceutical Production facility including procurement construction startup and
- validation
- Understanding of safety requirements working in a Biopharmaceutical Production facility.
- Independent selfmotivated organized able to multitask in project environments and
- skilled in communication facilitation and collaboration
- Phenomenal teammate prepared to work in and adopt a team based culture that relies on collaboration for effective decisionmaking
- Strong leadership technical writing and communication/presentation skills
Why is the Position Open
Supplement additional workload on team
Red Flags:
- No work experience
- No engineering or technical experience
- No collaboration experience
- No work gap of more than 3 months
Interview Process:
Webex panel.
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 websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
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