Engineering Lead

Fastnet The Talent Group

Sligo

Engineering Lead. We are recruiting an Engineering Lead to join our Leading Biopharmaceutical client in Sligo. This is a permanent role. The successful candidate will lead a team for the conjugation and fill finish facility, driving major projects and programs for an expanding site; drive cost savings, process and yield improvement projects to build operational excellence; manage the engineering change management function to ensure overall cGMP compliance; develop user requirements, functional and design specification for procurement, design, qualification of new processing equipment and automation system as required and provide SME engineering support for equipment trouble shooting, deviation investigations and product impact assessments. 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 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. Adheres to and supports all EHS & E standards, procedures and policies. Experience: Bachelor's Degree: Engineering or Relevant Discipline. 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. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2193 days ago