Biotech and Pharmaceutical, Commissioning, Commissioning - Engineering, Communication Skills, Cross-Functional, Detail Oriented, Equipment Validation, FDA (Food and Drug Administration), ICH Regulations, Identify Issues, Industry/Trade Analysis, Interpersonal Skills, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Operational Support, Problem Solving Skills, Process Validation, Regulations, Regulatory Compliance, Reporting Skills, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Standards Development, Technical Support, Time Management, Validation Plan, Validation Testing
Piper Companies is currently looking for an experienced (CQV) Commission Qualification Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical organization. The primary responsibility of this role is to assist with the IQ/OQ/PQ of new instruments/equipment in support of manufacturing operations
Responsibilities for the (CQV) Commission Qualification Validation Engineer include:
- Assist with the development of equipment validation protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines.
- Conduct equipment validation testing and generate validation reports.
- Provide technical support to manufacturing personnel and troubleshoot any issues related to equipment performance or quality.
- Collaborate with cross-functional teams to ensure timely completion of validation activities.
- Participate in risk assessments and provide recommendations for risk mitigation.
- Assist with the development and implementation of standard operating procedures related to equipment validation and qualification.
- Stay up-to-date with industry trends and regulations related to equipment validation and qualification.
Qualifications for the (CQV) Commission Qualification Validation Engineer include:
- Bachelor''s degree in Engineering or a related field.
- Minimum of 5+ years of experience in equipment commissioning and validation in a pharmaceutical or medical device manufacturing environment.
- Strong knowledge of applicable regulations and guidelines related to equipment validation (e.g., FDA, EU, ICH).
- Experience with IQ/OQ/PQ protocols, process validation, and risk assessment.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a cross-functional team
Compensation for the (CQV) Commission Qualification Validation Engineer include:
- Compensation Range is dependent upon experience
- Comprehensive benefits package
Keywords
GMP, Pharmaceutical Manufacturing, Equipment Qualification, Equipment Commissioning, Equipment Qualification, IQ/OQ/PQ, Comprehensive Benefits Package, Health, Vision, Dental.
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