6 LL01-061124 - Validation Engineer Jobs in Allentown, PA
Validation & Engineering Group is Hiring a LL01-061124 - Validation Engineer Near Allentown, PA
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Engineer
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
- 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.
Job Summary
Full Time
Business Services
$79k-97k (estimate)
06/24/2024
12/18/2024
veg-group.com
GUAYNABO, PR
50 - 100
1997
LUIS F PUIG
<$5M
Business Services
Related Companies
About Validation & Engineering Group
Validation & Engineering Group, Proudly serving our clients since 1997. Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage. Our agility in responding to our clients needs, access to the best pool of talent, and t...he combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries. At Validation & Engineering Group we provide professional expertise in the areas of: Audit and Assessment Automated Process Control System Qualification Equipment and Facilities Qualification Facilities Start-Up and Commissioning GAP Analysis Information Systems Computer Validation Packaging and Process Analysis Process & Cleaning Validation Project Management Quality Systems Risk Based Approach Regulatory Compliance Standard Operating and Maintenance Procedures Training Utilities Support and Qualification In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical. Our Offices: Puerto Rico: Centro Internacional de Mercadeo I100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico Phone: (787) 622-0996 United States 2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States Pjone: (770) 403-5802
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