Biologics Engineering Lead

Sigmar Recruitment

Sligo

Engineering Lead. Key Responsibilities: 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. 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. Assist with annual equipment qualification. Develops and reports key performance indicators ( KPIs) and engineering function reports to the senior management. 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. Initiate and develop preventative and demand maintenance programs along with calibration procedures. Qualifications: Bachelor’s Degree: Engineering or Relevant Discipline. Desired: Membership of the Institute of Engineers of Ireland (IEI. Experience: 7- 10 Years of progressive working in Pharmaceutical/Bio-pharmawith at least 3 years plus of direct management experience. Experience in cGMP Parenteral filling with Isolators ( vial filing is preferred. Demonstrated ability to lead and develop the engineering team. Experience with applying project management, validation and risk management processes. Experience interacting with and presenting to regulatory bodies such as FDA and HPRA. If you would like to apply to this exciting start up position please contact Clara on 01 4744676 or email your CV to chenry@sigmar.ie. This job originally appeared on RecruitIreland.com.

2219 days ago