Senior validation engineer Job

Sr. Validation Engineer is needed to perform the following duties:

· Responsible for performing ASTM test methods on package components for the product- package compatibility and package integrity qualifications of pharmaceutical products.

· Work closely with multi-disciplinary team of professionals internally and at contract manufacturers and track project deliverables.

· Works cross-functionally with Regulatory Affairs, Marketing, Engineers, and Quality Development groups to support operations, regulatory and risk requirements.

· Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.

· Manage a program for the Corporation for application of a risk-based decision making at every stage including ops quality, product development and manufacturing and post market control.

· Responsible for the project development associated to sustaining engineering activities for process, CAPA related projects, non- conformances, etc.

· Perform statistical analysis on data from Production line trials and qualifications to interpret performance capability.

· Performing Quality tools/methodologies including SPC, DOE, GR&R, pFMEA, CAPA, complaint investigation.

· Perform Process Validation (IQ/OQ/PQ) on the equipment.

· Performed HVAC Design Qualification as per URS of newly developed DPI facility and prepared a

HVAC DQ document as per WHO standards.

· Preparation of complete HVAC Heat Load Estimation Sheet to qualify the design.

· Performing and improving yield-based calculations for production line.

· Develop product and process verification and validation, technical justifications, test protocols, and reports in compliance with design control requirements.

· Identifies compliance gaps within own area of responsibility and proactively work towards their remediation.

· Developing and reviewing of computer system validation deliverables which include Validation Master Plan (VMP), Risk Assessment, Design qualification.

· Periodic review of computer system software on production equipment and maintaining the backups

· Responsible for reviewing, executing and closing out PV and PPQ protocols.

· Generation of Traceability Matrices, Risk Assessments, and other supporting documentation.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management

Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa

https://ndgcs.com/