Validation Specialist x2 - Oxford
- Recruiter
- Anonymous
- Location
- Oxford
- Salary
- Competitive
- Posted
- 24 Nov 2016
- Closes
- 09 Dec 2016
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
Alex Tosney is recruiting for two Validation Specialists to join a leading Biopharmaceutical company, based in Oxfordshire, on a full time, permanent basis. Our Client is a fast growing specialist biotech company who are leading the development of Gene and Cell therapy products. Offering a very competitive salary and benefits package, which will be discussed upon application.
As a Validation specialist your main responsibility will be to support GMP manufacturing facilities by ensuring all aspects of validation (equipment and facilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete and up to date. The Validation Team also represent the business in customer audits and regulatory inspections to demonstrate that the compliant systems.
As a Validation Specialist, you will have the following requirements and responsibilities:
?? Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements
?? Preparation and execution of validation protocols (equipment, computerised systems and processes)
?? Assisting system owners with impact assessments and identifying validation requirements.
?? Carrying out all validation activities on equipment before handover / return to system owner and updating all relevant records and schedules
?? Arranging specialist services to maintain, calibrate and qualify specialist equipment
?? Directing, instructing and supervising OEM technicians, fitters and contractors as required when external support is utilised for qualification activities
?? Maintaining validation equipment in a state of calibration and compliance to support the company's validation efforts
?? Creating / reviewing / maintaining qualification related records, procedures, documents and drawings
?? Ensuring compliance with safety, health and environmental (SHE) legislation
?? Engaging with project teams to help with selection, installation and commissioning of new equipment
?? Contribute to proactive management of asset preservation, energy reduction initiatives etc.
?? Any other task required from time to time to assist the efficient running of the Company's business.
As a Validation Specialist, you will have the following qualifications, skills and experience:
?? Demonstrable validation experience in a pharmaceutical, medical device, consumer healthcare or related industry
?? Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
?? Knowledge of building operating systems and utilities including commissioning, equipment validation and calibration
?? Knowledge of regulatory requirements for GMP and Biotech facilities operation and maintenance
?? Demonstrated effective interpersonal skills with an ability to interface well at all levels. Good oral and written communication skills
??A valid driving license is required for this vacancy
CK Engineers is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37659 in all correspondence
As a Validation specialist your main responsibility will be to support GMP manufacturing facilities by ensuring all aspects of validation (equipment and facilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete and up to date. The Validation Team also represent the business in customer audits and regulatory inspections to demonstrate that the compliant systems.
As a Validation Specialist, you will have the following requirements and responsibilities:
?? Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements
?? Preparation and execution of validation protocols (equipment, computerised systems and processes)
?? Assisting system owners with impact assessments and identifying validation requirements.
?? Carrying out all validation activities on equipment before handover / return to system owner and updating all relevant records and schedules
?? Arranging specialist services to maintain, calibrate and qualify specialist equipment
?? Directing, instructing and supervising OEM technicians, fitters and contractors as required when external support is utilised for qualification activities
?? Maintaining validation equipment in a state of calibration and compliance to support the company's validation efforts
?? Creating / reviewing / maintaining qualification related records, procedures, documents and drawings
?? Ensuring compliance with safety, health and environmental (SHE) legislation
?? Engaging with project teams to help with selection, installation and commissioning of new equipment
?? Contribute to proactive management of asset preservation, energy reduction initiatives etc.
?? Any other task required from time to time to assist the efficient running of the Company's business.
As a Validation Specialist, you will have the following qualifications, skills and experience:
?? Demonstrable validation experience in a pharmaceutical, medical device, consumer healthcare or related industry
?? Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
?? Knowledge of building operating systems and utilities including commissioning, equipment validation and calibration
?? Knowledge of regulatory requirements for GMP and Biotech facilities operation and maintenance
?? Demonstrated effective interpersonal skills with an ability to interface well at all levels. Good oral and written communication skills
??A valid driving license is required for this vacancy
CK Engineers is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37659 in all correspondence