Validation Engineer

5 days ago

Manila, National Capital Region, Philippines PSC Biotech® Corporation Full time
Overview

Validation Engineer role at PSC Biotech Corporation is a remote position supporting the schedule of M-F 8pm - 5am PH. This role focuses on Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering to ensure processes, equipment, and computerized systems meet regulatory requirements and industry standards.

Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Execute computer system validation activities, including defining user requirements, developing test scripts, and conducting validation testing.
  • Collaborate with cross-functional teams to ensure that systems and processes meet regulatory and quality standards.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
  • Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Participate in change control processes to assess the impact of changes on validated systems.
  • Investigate and resolve deviations related to validation activities, ensuring compliance with regulatory requirements.
  • Proactively identify opportunities for process improvements in validation activities.
  • Stay abreast of industry trends, regulatory changes, and best practices related to CQV and CSV.
  • Additional responsibilities as required.
Qualifications
  • Bachelor's degree in Engineering or related technical field.
  • Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry.
  • Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
  • Strong technical writing and documentation skills.
  • Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Detail-oriented with strong organizational abilities.
Equal Opportunity Employment

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions and employer-sponsored activities and programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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