Validation Specialist

1 week ago


New Brunswick, New Jersey, United States Sun Pharmaceutical Industries Full time
Job Title: Validation Specialist

Job Summary:

The Validation Specialist is responsible for ensuring the quality and compliance of equipment, packaging, and utilities in a pharmaceutical manufacturing environment. This role requires a strong understanding of regulatory requirements and the ability to develop and execute validation protocols.

Key Responsibilities:
  • Develop and execute URS, IQ/OQ/PQ protocols and write summary reports for production and packaging equipment, utilities, and area qualification.
  • Ensure that assigned validation activities are performed timely and in line with current requirements and regulatory standards.
  • Coordinate commissioning activities for engineering projects of new areas and equipment.
  • Review and execute PPV (Periodical Performance Verification) of equipment.
  • Develop calibration plans for new equipment.
  • Prepare and train on SOPs for setup, operation, cleaning, and maintenance.
  • Identify, investigate, and troubleshoot deviations for multiple concurrent projects.
  • Prepare personnel flow, incoming and finished material flow, and waste flow in the facility.
  • Assist in preparation of internal audit, regulatory agency audit responses.
  • Prepare, review, approve, and maintain validation project plans and summary reports.
Requirements:
  • Bachelor's Degree in Engineering or Science-related field.
  • Technical and analytical ability to analyze engineered systems and equipment operation.
  • Good understanding of regulatory requirements and good documentation practices.
  • Technical knowledge to write, prepare, and execute change controls, investigations, SOPs, protocols, and validation documents.
  • Excellent communication, verbal, written, and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • A team building champion driving innovative cross-functional synergies.
  • Excellent project management and problem-solving skills.
Company Overview:

Sun Pharmaceutical Industries is a leading pharmaceutical company dedicated to improving patient outcomes through innovative products and services. Our team is passionate about delivering high-quality products and services that meet the needs of our customers and patients.

Benefits:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Flexible work arrangements and work-life balance.
Equal Employment Opportunity:

Sun Pharmaceutical Industries is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.



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