Analysis Skills, Biotech and Pharmaceutical, Calibration, Cost Effectiveness Analysis, Data Analysis, Equipment Maintenance/Repair, Industry Standards, Leadership, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Mentoring, Process Improvement, Quality Assurance, Quality Engineering, Regulations, Risk Management, Statistics, Strategic Planning, Team Lead/Manager, Technical Recruiting, Validation Plan
Contract Type: W2
Duration: 12 Months
Location: Greenville, NC - 27834 (Onsite)
Pay Range: $90 - $100 per hour on W2
Job Summary:
As a Senior Validation Engineer in the biotech sector, you will be responsible for leading the development and execution of comprehensive validation master plans. This role entails managing both internal engineers and external consultants, ensuring compliance with industry standards, and optimizing manufacturing processes for efficacy and cost-effectiveness. The position requires a proactive approach, overseeing the entire lifecycle of validation activities from strategic planning through execution and analysis.Key Responsibilities:
- Mentor and manage team activities within the validation master plan, offering regular progress updates to senior management.
- Design and implement validation strategies that comply with regulatory and organizational standards.
- Oversee the execution of validations and qualifications, ensuring systems and processes meet stringent criteria.
- Analyze validation data critically to verify system performance and compliance.
- Collaborate across departments to efficiently schedule and implement validation efforts.
Must-Have Skills:
- Proficient in writing and managing validation protocols and reports.
- Strong capability in statistical data analysis and applying risk management principles.
- Deep knowledge in calibration and maintenance of technical equipment.
Industry Experience Required:
- Minimum of 11-15 years in biotechnology manufacturing or related fields, focusing on quality assurance, engineering, or validation activities.
Your expertise will drive the assurance of product quality, consistency, and compliance, directly impacting the success and growth of our biotechnological innovations.
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