Are you a Validation Engineer with experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Validation Engineer - Aseptic - Waterford
Employer
Our Client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland’s top 10 best large workplaces by Great Place to Work Ireland
Job Description
The Validation Engineer role is to ensure that facilities, equipment, systems and processes associated with both solid dosage forms and sterile product manufacturing are validated in accordance with cGMPs.
The activities would include;
Deliver the validation site strategy in a safe, compliant manner and to the highest standard of performance.
Planning, execution and reporting the on-going validation compliance of facilities, equipment, systems and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.
Right first time execution of re-qualifications, quality reviews, computer systems periodic reviews and to scheduled timeline
Maintain compliant validation systems/processes on-site, including the maintenance of the site validation master plans.
Provide validation expertise, technical support and knowledge to site cross functional teams.
Assessment, review and approval of change controls to maintain validation status.
Generation, review and approval of validation risk assessments as appropriate.
Lead/support validation investigations as appropriate using root cause analysis methodologies.
Actively participate in a positive team environment where support, challenge, empowerment and continuous learning/knowledge exchange is encouraged.
Preparation and maintenance of departmental metrics to internal and external stakeholders
Proactive participation & validation representation at key site meetings and regulatory inspections
Support MWI process and ensure timely closure of Deviations, Events, CAPAs, LCRs & Tasks etc
Implement continuous improvement initiatives within validation
Requirements:
3rd level Science or Engineering qualification.
3-4 years relevant experience in a highly regulated GMP environment.
Experience of Sterile Manufacturing Operations
Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities.
Capable of troubleshooting validation issues associated with projects, process development etc.
Application of risk-based approach to validation
Knowledge of industry and regulatory requirements for sterile and non-sterile facilities and processes.
Understanding of relevant quality and compliance regulations
Effective project management skills.
Detailed knowledge of quality management systems.
Good communication skills at organisation, team and individual levels.
Ability to use MS Project and SPC packages an advantage
Understands KPI’s for the team and the site.
Package:
Contract rate dependent on prior experience
€30+ per hour
Contract duration: 12 - 18 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Waterford
Validat
Are you a Validation Engineer with experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Validation Engineer - Aseptic - Waterford
Employer
Our Client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland’s top 10 best large workplaces by Great Place to Work Ireland
Job Description
The Validation Engineer role is to ensure that facilities, equipment, systems and processes associated with both solid dosage forms and sterile product manufacturing are validated in accordance with cGMPs.
The activities would include;
Deliver the validation site strategy in a safe, compliant manner and to the highest standard of performance.
Planning, execution and reporting the on-going validation compliance of facilities, equipment, systems and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.
Right first time execution of re-qualifications, quality reviews, computer systems periodic reviews and to scheduled timeline
Maintain compliant validation systems/processes on-site, including the maintenance of the site validation master plans.
Provide validation expertise, technical support and knowledge to site cross functional teams.
Assessment, review and approval of change controls to maintain validation status.
Generation, review and approval of validation risk assessments as appropriate.
Lead/support validation investigations as appropriate using root cause analysis methodologies.
Actively participate in a positive team environment where support, challenge, empowerment and continuous learning/knowledge exchange is encouraged.
Preparation and maintenance of departmental metrics to internal and external stakeholders
Proactive participation & validation representation at key site meetings and regulatory inspections
Support MWI process and ensure timely closure of Deviations, Events, CAPAs, LCRs & Tasks etc
Implement continuous improvement initiatives within validation
Requirements:
3rd level Science or Engineering qualification.
3-4 years relevant experience in a highly regulated GMP environment.
Experience of Sterile Manufacturing Operations
Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities.
Capable of troubleshooting validation issues associated with projects, process development etc.
Application of risk-based approach to validation
Knowledge of industry and regulatory requirements for sterile and non-sterile facilities and processes.
Understanding of relevant quality and compliance regulations
Effective project management skills.
Detailed knowledge of quality management systems.
Good communication skills at organisation, team and individual levels.
Ability to use MS Project and SPC packages an advantage
Understands KPI’s for the team and the site.
Package:
Contract rate dependent on prior experience
€30+ per hour
Contract duration: 12 - 18 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Waterford
Validat
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
