What are the responsibilities and job description for the LL01-061124 - Validation Engineer position at Pinnaql?
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Engineer
Duration: 3 months (On Site)
Responsibilities:
- Experiences in Commercial Secondary Packaging of vials, and pre-filled syringes.
- Experience in Process Validation
- Responsible for the preparation of the following documents:
- Validation Project Plan (VPP), and its Summary Report
- Combined Validation Strategy (Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis)
- Client Specific Operational Qualification, and its Summary Report
- Process Performance Qualification (PPQ) Protocol development and execution, as well as the generation of their corresponding summary report.
- Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies
- Work closely with process engineering and project managers to coordinate and execute PPQ activities and protocols.
- Provide constant communications with all affected departments and personnel regarding validation activities
- Other duties may be assigned to meet business needs
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.