C&Q Program Lead (Contractor) – 12 month
A C&Q Program Lead contractor is required to oversee and coordinate C&Q projects for conjugation and aseptic filling projects at a state-of-the-art Biologics aseptic fill finish facility in Sligo.
- Planning and coordination of C&Q activities in line with a risk-based approach (RBV).
- Support concept design, detailed design development and planning.
- Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
- Assessment of third-party C&Q support and / or the assessment of individual candidates for specific project roles.
- Manage C&Q teams / team coordinators to deliver key GE lead projects across the network.
- Track project progress in line with agreed schedules week on week.
- Support issue resolution through close working ties with the cross functional teams.
- Support protocol execution and reporting activities when required.
- Provide guidance and advisement to C&Q personnel.
- Some international Travel to support C&Q execution and management of FAT’s as well as on site execution activities.
- Assist with feasibility analysis such as cost / timeline estimations for new project proposals.
- Work closely with key GE members and central services personnel to upskill. Become proficient with global engineering standards with particular focus on qualification and validation as well engineering standards specific to facilities, Utilities and Equipment.
Education & Experience
- Degree in a Science, Engineering, or computer science discipline
- Minimum 5 years’ experience in the pharmaceutical industry in a C&Q / Validation role.
- Extensive Knowledge of Pharmaceutical Regulatory Requirements.
- Experience in working with Pharmaceutical Equipment Manufacturers.
- Multi-disciplinary experience: Facilities, Utilities, Equipment, Cleaning, Sterilization, Inspection, Computer System Validation and Process validation.
- Must have previous experience in a project management role, managing of a team of C&Q engineers
- Experience in Risk based Verification (RBV).
- Detailed Understanding of risk-based verification requirements for facility, utility, and equipment (FUE) qualification.
- Experience with conjugation and aseptic fill finish manufacturing practices.
- High degree of knowledge of all relevant EU/FDA regulations.
- Strong understanding of current data integrity and data management requirements.
- Demonstrated ability to coordinate activities in an efficient and effective manner.
- Experience with paperless validation solutions such as Kneat would be beneficial.
- Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
For a confidential discussion and more information on the role, please contact Davin Ferguson.