Alcon
Cork, Ireland
Job Description
Reporting to the Engineering Manager MS&T Site Head you will develop, plan, implement and manage Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. You will be the MS&T Validation Lead for the Cork Site.
On a daily basis you will be required to demonstrate your strong engineering expertise, your excellent interpersonal skills, your knowledge of FDA and cGMP validation requirements, your strength in problem solving and your fit within an environment where ownership of results and adherence to standards and procedures is routine.
Key responsibilities include:
- Establish, generate and, maintain Site Validation Master Plan and associated technical SOPs for all validation, revalidation and periodic review activities on-site;
- Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process to the required technical standards;
- Assess and approve Change Control proposals to ensure validation strategy is consistent with Alcon validation requirements;
- Establish and manage the individual project validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs. Review risk assessments for validation;
- Maintain governance of all validation activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities;
- Advise validation practitioners on all aspects of validation planning, testing strategy and execution;
- Identification of future budgetary requirements for the area;
- Manage costs within budget and identify & implement productivity improvement opportunities;
- Support equipment and process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering;
- Provide assessment of and input to Quality Modules (QM)/Quality Directives (QD)/global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure documents are in line with global/local requirements and industry standards;
- Participate in improvement and remediation of products;
- Liaise with external customers and other Alcon sites as part of daily role;
- Engage with broader Alcon Validation Lead community to benchmark best practice in validation approaches and collaborate in implementing global MS&T vision.
Minimum requirements
Candidates should have:
- Degree in Engineering, Technology or similar technical discipline;
- Extensive Equipment and Process & Software Validation experience;
- At least 8 years’ experience in manufacturing/manufacturing science and technology/technical development/Quality with direct experience in a validation role in either medical device or pharmaceutical industry;
- 5 years’ experience in executing process validation, having led and managed validation projects;
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities;
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions);
- Demonstrable knowledge of FDA, medical device, cGMP and validation requirements;
- Excellent communication and skills – written, oral and pc.