Validation Analyst

Overview

Validation Analyst I is responsible for overall validation project management of small customer accounts under heavy supervision. The role involves generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs.

• Perform validation activities to assure compliance with government and customer requirements.
• Prepare validation protocols, statements, and master validation plans for new customer, product, or system launches; maintain validated processes and programs at multiple sites.
• Ensure validation package documentation completion, accuracy, and closure; organize and coordinate internal and customer approvals.
• Prepare change control and validation history reports for customer audits.
• Participate in conference calls and customer meetings; communicate project goals and progress to Validation Supervisor/Manager.
• Investigate validation deviations, document formal reports, and assure resolution of corrective actions.
• Serve as customer contact for quality validation activities and manage expectations.
• Review and interpret customer standards, procedures, and specifications for dissemination relative to process and cleaning validation protocols.
• Review production jackets and ensure documents meet internal standards and procedures.
• Adhere to PCI, cGMP, GCP, GAMP, 21
  
  CFR, 21
  
  CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
• Complete a “Documentation Boot Camp” course.
• Perform overtime and/or weekend work as required.
• Perform other duties as assigned.

• High School Diploma or GED with 1–3 years of related experience or training, OR equivalent knowledge.
• Basic mathematical and computer skills.
• Professional proficiency in written and verbal communication.
• Intermediate reasoning and problem‑solving abilities.
• Attention to detail, independence, teamwork, and willingness to make decisions.
• Ability to follow instructions and adapt to changing work environments.
• Effective communication with diverse audiences.
• Passion for quality and compliance in a regulated environment.

Competitive salary range: $19.96 – $22.46 per hour plus an annual performance bonus.

Full‑time employees receive a comprehensive benefits package including paid time off, health, dental, and vision insurance, flexible spending account, and 401(k) plan.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, equity and inclusion are at the core of our purpose.

We are committed to cultivating an inclusive workplace and ensuring a fair and respectful environment for all employees.