Quality Assurance Validation Specialist
1 week ago
PACIV, a global leader in control systems integration and regulatory compliance engineering, is seeking a dedicated Validation Engineer (Level I) for our USA operations.
Role Summary:
The Validation Engineer will oversee the management of various commissioning, qualification, and validation processes within our client's Biotechnology and Pharmaceutical facilities. This role will involve collaboration with the client's validation, project management, quality assurance, and automation teams.
Key Responsibilities:
- Implement System Lifecycle deliverables from Commissioning and Qualification (C&Q) and Computer System Validation (CSV) documentation through to System Retirement.
- Engage actively with cross-functional teams to support project goals, ensuring timely delivery and adherence to quality standards.
- Assist in the execution of significant product launches, small capital projects, and process enhancements related to manufacturing and laboratory systems.
Qualifications:
- Bachelor's or Master's degree in Engineering or a related technical field.
- 1 to 3 years of validation experience within the Pharmaceutical sector.
- Ability to thrive in a 24/7 manufacturing setting.
- Strong teamwork skills and accountability.
- Capacity to manage high-pressure and high-stress situations.
- Results-oriented and self-driven.
- Excellent interpersonal and communication skills, both verbal and written.
- Highly organized with proficiency in MS Office applications such as Word, Project, and Excel.
Preferred Skills:
- Understanding of Validation principles and deliverables (e.g., Requirements, Design, Testing, Reports).
- Experience with CSV, particularly concerning Data Integrity and CFR Part 11 Electronic Records and Signatures.
- Project Management experience with the ability to lead projects to successful completion independently.
Additional Information:
Travel may be required up to 25% for visits to various suppliers and client sites.
Compensation:
We offer a competitive salary and benefits package, including:
- Paid Time Off (PTO) for vacation, illness, and company holidays, accrued throughout the year.
- Health Insurance with PACIV covering 90% of the premium.
- Basic Life Insurance coverage for all full-time employees.
- 401(k) Retirement Plan with company matching contributions.
- Performance bonuses for eligible projects and employees.
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