Validation Engineer

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 industry.

We are looking for two (2) Validation Resources for the Engineering Services Department with our LA area pharmaceutical client. The Qualification Engineer will play a critical role in ensuring the Risk-Based Monitoring (RBM) qualification meets all operational and regulatory requirements, facilitating its seamless implementation, and ensuring the successful validation of equipment supporting the quality control operations according to our client's standard operating procedures.

Equipment:

• Biological Safety Cabinets (BSC)
• Freezers (-80°ree;C)
• Refrigerators
• Incubators (CO₂)
• Water Baths
• Decommissioning of legacy equipment
• Integration: Standalone equipment
• Resources: Two (2) Validation Engineers

List of Responsibilities:
The responsibilities for the validation resource will be assigned by the Engineering Services Team, as needed, and will include but are not limited to the following:

• Lifecycle Documentation: Responsible for the development of protocol, and function as a document owner during the review and approval of the documentation according to Takeda procedures, including but not limited to system/risk assessments, User Requirements Specification (URS), Design Qualification (DQ), Change Management documentation, and other specifications.
• Installation Qualification (IQ): Develop documents as coordinator/owner according to Takeda procedures, execute, and complete for closure IQ protocols to verify that the equipment is installed according to design specifications.
• Operational Qualification (OQ): Develop documents as coordinator/owner according to Takeda procedures, execute, and complete OQ protocols to ensure the equipment functions according to its intended use and in accordance with specifications.
• Performance Qualification (PQ): Develop documents as coordinator/owner according to Takeda procedures, execute, and complete PQ protocols to ensure the equipment functions according to its intended use and in accordance with specifications.
• Cycle Development: Support cycle development protocols execution.
• Change Management: Function as the change owner according to Takeda procedures during the qualification stage/phase of the project.
• Discrepancies: Initiate and complete protocols discrepancies according to Takeda procedures.
• Traceability Matrix and Summary reports: Function as document coordinator/owner of requirements traceability reports and qualification protocols summary reports.
• Training: Maintain current training on relevant Standard Operating Procedures (SOPs).

Deliverables:

• Protocols and Documentation: Generate and gain approval for all necessary protocols and lifecycle documentation according to the project timeline.
• Execution of IQ/OQ: Complete execution of IQ and OQ protocols on time according to project schedule.
• Execution of PQ: Complete execution of PQ protocols on time according to project schedule.
• Final Report IOQ: Generate and route for approval the Test Summary Report and Final Validation Reports on time according to project schedule.

Qualifications:

• 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.
• Knowledge of cGMP and other regulatory standards.
• Experience with pharmaceutical process equipment and instrumentation.
• Proficiency in Equipment and Process Validation
• Excellent problem-solving and troubleshooting skills
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• Exceptional technical writing, review and analytical skills.

SALARY RANGE FOR THIS ROLE IS $95,000 - $115,000 ANNUALLY FOR A W2 EMPLOYEE

SALARY RANGE FOR THIS ROLE IS $90,000 - $115,000 ANNUALLY FOR A W2 EMPLOYEE

VTI Life Sciences strives 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. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 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, VTI is 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. www.validation.org

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