Sterility Assurance Lead

Prochem Engineering; Waterford; On-site; EUR 65,000 - 95,000; Full time

Job summary

Prochem Engineering in Waterford, Ireland, seeks an experienced Sterility Assurance professional to oversee on-site activities and develop strategies to ensure product sterility and regulatory compliance.

You will lead investigations, manage breaches, review commissioning and validation documentation, mentor staff, and drive continuous improvement through cross-functional collaboration and industry benchmarking.

Qualifications

• Honours degree in Microbiology or related discipline.
• Postgraduate studies are preferred.
• Significant experience in sterile pharmaceutical manufacturing and sterility assurance.
• Experience supporting regulatory inspections.
• Strong technical writing and report writing skills.
• Ability to collaborate effectively across cross-functional teams.

Responsibilities

• Develop and support strategies for sterility assurance and contamination control.
• Lead major sterility assurance investigations.
• Provide advice and support for investigations or projects related to sterility, environmental excursions or contamination concerns.
• Review documents related to commissioning, qualification, process validation, and regulatory aspects.
• Participate in audits/inspections focusing on sterility assurance.
• Benchmark best industry practice through networking and events.

Skills

Sterility assurance

Environmental monitoring

Technical writing

Cross-functional collaboration

Regulatory inspections support

Education

Honours degree in Microbiology or related

Postgraduate studies

Job description

• Reporting to the QA Manager, the successful candidate will be responsible for oversight and development of all sterility assurance activities on site as well as the development of sterility assurance and contamination control strategies.

Job Requirements:

• Development of and support for implementation of strategies regarding:


• Media Fill


• Environmental Monitoring and Performance Qualification


• Decontamination, sterilisation and Depyrogenation


• Management and prevention of sterility breaches such as leaks or glove damage


• Gowning for classified area


• Lead major sterility assurance investigations


• Provide advice and support for significant investigations or projects related to sterility assurance, environmental excursions or contamination concerns.


• Review documents related to commissioning, qualification, performance qualification, process validation, risk assessment and regulatory related to sterility assurance aspects.


• Benchmark best industry practice through networking and attendance at key industry events.


• Review of specifications for consumables relating to biological indicators and product specifications regarding microbiological parameters.


• Provides quarterly and annual sterility assurance updates.


• Contributes to personnel qualifications programme design, training and development of individuals relating to sterility assurance relevant topics through ongoing proactive training, mentoring and communication.


• Participates in the determination and introduction of new technologies related to sterility assurance.


• Participates in audits/inspections/visits, both internal and external focusing on sterility assurance aspects.

Qualifications

• Honours degree in Microbiology or a related discipline


• Post Graduate studies as appropriate


• Significant experience in sterile pharmaceutical manufacturing and sterility assurance.


• Experience supporting regulatory inspections


• Strong technical writing, report writing skills.


• Ability to collaborate effectively across cross-functional teams.