Description
Senior Validation Engineer required for pharmaceutical manufacturing plant based in Ireland.We are seeking a Validation Engineer with circa 10 years' experience, ideally with managerial exposure to oversee a team of up to 3-4 Engineers and act as SME on the requalification activities and validation masterplan for their filling line on site.
The Senior Validation Engineer will be responsible for the validation of new drug products processes/equipment to the facility, and will manage and provide oversight of validation of equipment and systems at their Manufacturing Facility. This role will be primarily focused on the validation ownership of all equipment on site. You will develop and implement a robust validation program in line with best industry practice and current regulatory expectations and will also manage an ongoing requalification, periodic review and continuous process verification programs to ensure that all GMP manufacturing processes are maintained in a validated state and in control.
Equipment includes:
- Autoclaves.
- Depyrogenation tunnel.
- VHP.
- Isolator.
- Temperature Control Units.
- Freezers.
- Cold Rooms.
- Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
- Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs.
- Process mapping and gap analysis.
- Review of equipment specification/design/procurement/installation and validation.
- Project planning and execution including scheduling, task management, milestone planning and reporting.
- Delivering projects on time and on budget.
- Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
- Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc).
- Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
- Minimum of 8 years' experience in a cGMP biopharmaceutical or aseptic filling environment.
- Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
- Strong validation knowledge equipment of such as Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems.
- Filling Line experience
- Must have direct experience of performing validation studies of thermal sterilisation processes including Autoclave validation, Steam in Place (SIP) validation, and validation of depyrogenation processes.
- Experience of supervising personnel is required as this role will have direct reports.
- Must have experience managing complex, multifunctional projects.
- Experience in HPRA/FDA environment is required.
- Problem solving and Project Management skills essential.
- Must be goal-oriented and able to prioritise and manage tasks.
- Bachelor's degree required as a minimum; eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.