The Validation Specialist join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. The Validation Specialist will be responsible for executing and reviewing revalidations, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to support validation protocols and investigations. This role is essential in maintaining the accuracy of validation processes, identifying root causes of failures, and implementing corrective actions to enhance efficiency and quality.
Responsibilities of the Validation Specialist:
Revalidation & Compliance Oversight:
- Perform and review equipment/process revalidations in alignment with approved timelines.
- Ensure validation protocol data meets documented acceptance criteria.
- Author and review validation documents to comply with corporate and regulatory guidelines.
Validation Process Management:
- Collaborate on IQ, OQ, and PQ protocols for systems and processes.
- Support investigations using root cause analysis techniques and implement corrective actions to prevent failures.
- Oversee Change Requests (CRs) for validation activities.
- Provide expertise during audits and inspections to validate compliance approaches.
Continuous Improvement & Quality Assurance:
- Participate in continuous improvement initiatives using cLEAN methodology.
- Establish validation procedures, specifications, and quality documents for accuracy and compliance.
- Uphold all safety and environmental standards in daily operations.
Qualifications of the Validation Specialist:
- Bachelor’s Degree in Engineering, Computer Science, or a related technical field.
- Minimum 2 years of validation experience within the pharmaceutical or medical device industry.
- Knowledge of core validation areas such as sterilization, cleaning, process validation, or computer validation.
- Familiarity with cGMP documentation and regulatory standards.
- Strong proficiency in Microsoft Word, Excel, and validation tracking tools.
- Experience with validation test equipment, including temperature mapping (e.g., Kaye Validator).
- Strong analytical, problem-solving, and organizational skills.
Compensation & Benefits:
- Competitive salary, based on experience, average rate around: $32-38/hr
- Full benefits package including Medical, Dental, Vision, 401K, PTO, Sick Leave, and Holidays.
Key Words: Validation Specialist, Pharmaceutical Validation, Revalidation, IQ/OQ/PQ, Root Cause Analysis, cGMP Compliance, Change Control, Process Validation, Sterilization, Cleaning Validation, Technical Documentation, Audits & Inspections, Quality Assurance
If you are passionate about ensuring high standards in validation, compliance, and process improvement, we encourage you to apply today!
This job opens for applications on 5/1. Applications for this job will be accepted for at least 30 days from the posting date.
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