Overview
On Site
USD 35.00 - 43.00 per hour
Full Time
Skills
Pharmaceutics
IQ
OQ
PQ
Management
Documentation
Regulatory Compliance
Root Cause Analysis
Continuous Improvement
Auditing
GMP
Communication
Project Management
Biotechnology
Law
Job Details
Piper Companies is seeking a Validation Area Specialist to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Clayton, North Carolina (NC). The Validation Area Specialist will ensure quality and compliance in biotech processes by conducting validations, managing documentation, and leading technical investigations while collaborating across departments.
Responsibilities of the Validation Area Specialist include:
Qualifications for the Validation Area Specialist include:
Compensation for the Validation Area Specialist:
This job opens for applications on 4/30. Applications for this job will be accepted for at least 30 days from the posting date.
Responsibilities of the Validation Area Specialist include:
- Execute and review validation processes (IQ/OQ/PQ) while managing change requests and documentation in compliance with regulatory standards
- Lead investigations using root cause analysis and implement corrective actions within cross-functional teams
- Author and review validation procedures, specifications, and quality documents while ensuring data accuracy
- Support continuous improvement initiatives and represent validation approaches during audits
Qualifications for the Validation Area Specialist include:
- Minimum of 2 years of experience of validation of equipment in a GMP environment
- Strong technical expertise with validation processes (sterilization, cleaning, computer) combined with excellent communication and project management skills
- Bachelor's degree in Engineering, Biotechnology, or a related field.
Compensation for the Validation Area Specialist:
- Salary Range: $35-$43/hour (USD)
- Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
This job opens for applications on 4/30. Applications for this job will be accepted for at least 30 days from the posting date.
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