- Coordinate with cross-functional departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering.
- Support FMEA activities.
- Support HAZOP processes.
- Perform Risk Assessments.
- Perform Gap Assessments.
- Turnover Package Generation.
- Project Change Requests.
- Support the client and their A/E Firm in Project Design.
- Generate and Manage Safety Management Plans and Documentation.
- Generate and Manage Quality Management Plans and Documentation.
- Assist in site supervision of construction personnel.
- Manage Installation and Operational Commissioning.
- Support site acceptance testing to review system documents and functions during SAT.
- Generate Summary Report.
- Bachelor's degree or higher in Engineering, Life Sciences, or related discipline (Mechanical Eng., Chemical Eng., Chemistry, Biology, etc.).
- 5+ years of relevant FDA regulated industry experience as a Project Engineer.
- Knowledge of cGMP and other regulatory standards.
- Proficiency in process engineering and process optimization techniques.
- Experience with pharmaceutical process equipment and instrumentation.
- Excellent problem-solving and troubleshooting skills
- Strong leadership, project management and client management skills
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
- Exceptional technical writing, review and analytical skills.
- Knowledge of good documentation practicesandcGMP.
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Pharmaceutical Project Engineers - California, United States - VTI Life Sciences
Description
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.
We are looking for Four (4) Project Engineers to helpsupport engineering and CQV activities related to equipment and systems affected by the project expansion at our client's pharmaceutical facility in the Greater Los Angeles area.
RESPONSIBILITIES:
Qualifications:
SALARY RANGE FOR THIS ROLE IS $95,000 - $120,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.VTIoffers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations,VTIis always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
