Biologics Engineering Lead
Our client, a multinational pharmaceutical organisation are currently recruiting for a Biologics Engineering Lead to join their team. This is a permanent opportunity based in Sligo and as Biologics Engineering Lead you will have the opportunity to drive major projects and programs for an expanding site.
• Establish with the Engineering manager the department goals, schedules and timetables for activities
• Lead the development and execution of acceptance test and qualification protocols
• Build and maintain relationships with strategic engineering vendors to facilitate the introduction of best available technology where applicable
• Manage vendors, engineering consultants and contractors to support capital long range planning and project execution
• Lead supplier qualification activities for processing and automation equipment suppliers
• Support the planning and execution of tech transfer for new products coming into the facility
• Assist with annual equipment requalification; optimize schedule of requalification to minimize lost production time.
• Leads complex deviation investigations and implementation of corrective and preventative actions (CAPAs); ensures deviations and CAPAs are completed in a timely manner to support batch release requirements
• Develops and reports key performance indicators ( KPIs) and engineering function reports to the senior management
• Lead any annual equipment requalification and optimize schedule of requalification to minimize lost production time
• Ensure the engineering function is in full compliance with cGMP requirements including audits and inspections
• Manage department engineering capital and expense budgets to a monthly basis.
• Maintain appropriate staffing levels and collaborate with Human Resources for new engineering hires
• Initiate and develop preventative and demand maintenance programs along with calibration procedures to support the operation of facility
• Identify appropriate training programs for the engineering team and ensure timely completion of training activities
• Bachelor’s Degree: Engineering or Relevant Discipline
• Membership of the Institute of Engineers of Ireland (IEI)
• 7- 10 Years of progressive working in Pharmaceutical/Bio-pharma preferably in a parenteral facility with at least 3 years plus of direct management experience
• Experience in cGMP Parenteral filling with Isolators (vial filing is preferred) through to final container closure
• Demonstrated ability to lead and develop the engineering team
• Must be self-motivated, have strong attention to detail, ability to work independently and in team settings
• Experience with applying project management, validation and risk management processes to the facility and manufacturing and control systems.
• Lead and provide support for innovations and implementation of process improvements for the facility
• Must be goal-oriented, quality conscious and team focused
• Experience interacting with and presenting to regulatory bodies such as FDA and HPRA
• Strong verbal, written and presentation communication skills
• Strong knowledge of the latest industry issues and trends
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252