Location: South Co. Dublin
Employer Profile:
Our Client discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, our Client was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Today, as a Fortune 500 company serving millions of patients, our client continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
Job Description:
As a Cleaning validation engineer, you will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Responsibilities:
• Development of Cleaning Validation Strategy, Validation Plans, Protocols and Reports for all cleaning processes for a Sterile Fill Finish Facility.
• Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
• Load Configuration and cycle development, Cleaning Verification and Cleaning Validation.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
• Generate and execute protocols and assessments from a quality system documentation perspective for CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
• Participate as required in project activities.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
Requirements:
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Extensive Parts, Equipment and Vessel Cleaning Experience essential
• Experience in Time Pressure Filling CIP an advantage
• Component Preparation Commissioning Experience an advantage
• Minimum 2 years experience in a similar role.
• A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
12 months minimum contract
Rate: €40-45/hour
Day and Evening Shift Rotation with Shift allowance payments
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mailkaren@jobcontax.com or phone +353-1 7978720Job Title: Validation Engineer - Cleaning
Location: South Co. Dublin
Employer Profile:
Our Client discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, our Client was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Today, as a Fortune 500 company serving millions of patients, our client continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
Job Description:
As a Cleaning validation engineer, you will be responsible for ensuring that the Cleaning Validation Activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
Responsibilities:
• Development of Cleaning Validation Strategy, Validation Plans, Protocols and Reports for all cleaning processes for a Sterile Fill Finish Facility.
• Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
• Load Configuration and cycle development, Cleaning Verification and Cleaning Validation.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
• Generate and execute protocols and assessments from a quality system documentation perspective for CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
• Participate as required in project activities.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
Requirements:
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Extensive Parts, Equipment and Vessel Cleaning Experience essential
• Experience in Time Pressure Filling CIP an advantage
• Component Preparation Commissioning Experience an advantage
• Minimum 2 years experience in a similar role.
• A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
12 months minimum contract
Rate: €40-45/hour
Day and Evening Shift Rotation with Shift allowance payments
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mailkaren@jobcontax.com or phone +353-1 7978720
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
