Validation Consultant/Talent Bank

All Puerto Rico, Puerto Rico
Contracted
Mid Level

STG is seeking a highly skilled and detail-oriented Validation Consultant to join our team. The ideal candidate will be responsible for planning, executing, and documenting validation activities for equipment, processes, and systems to ensure compliance with regulatory standards and internal quality requirements. This role is essential in maintaining our commitment to delivering safe and effective products to our customers.

Key Responsibilities
  • Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
  • Perform validation activities including qualification of facilities, utilities, equipment, and computerized systems.
  • Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
  • Collaborate with cross-functional teams including engineering, production, and quality departments to support validation efforts.
  • Conduct risk assessments, deviations, and impact assessments to identify and mitigate potential issues.
  • Prepare and review validation documentation such as protocols, reports, and standard operating procedures (SOPs).
  • Troubleshoot and resolve validation issues to ensure timely project completion. Maintain up-to-date knowledge of industry trends, regulatory changes, and technological advancements in validation processes.
Qualifications
  • Bachelor’s degree in Engineering or  Science
  • Minimum of 4+ years of experience in validation within a regulated industry (pharmaceutical, biotech, medical device, etc.).
  • Strong knowledge of regulatory requirements (FDA, EU, cGMP) and validation best practices.
  • Experience with validation of equipment,  processes,  and software systems. Proficiency in validation documentation and technical writing.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Excellent analytical and problem-solving skills.
  • Strong attention to detail and organizational skills.
Preferred Skills
  • Certification in Quality, Validation, or Regulatory Compliance (e.g., ASQ, CQE, etc.).
  • Experience with software validation (CSV) and computerized system validation. Familiarity with automation systems and instrumentation. Knowledge of risk management tools such as FMEA (Failure Modes and Effects Analysis).

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

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