Process Engineer - Midlands - Open On Sa

CPL

Westmeath

Overall Purpose: You will provide technical support and expertise in the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of a new Irish manufacturing facility. For the on-going commercial operation of the facility, the Process Engineer will provide key technical support in the areas of process control, manufacturing process troubleshooting, process optimization, process development, and product transfer. The Process Engineer will report to the Technical Services Manager. Essential Duties, Functions and Responsibilities: Provides technical support and trouble-shooting in support of manufacturing, validation and maintenance activities. Investigates and resolves process or product deviations. Optimizes product yield and cycle time. Leads continuous improvement projects and initiatives. Supports and champions new product introductions. Acts as technical representative for assessment and development of process change control and regulatory submission proposals. Provides training and mentoring to build technical capabilities among teams. Supports capital projects throughout equipment lifecycle. Supports product or process development projects and associated validation activities. Skills/Knowledge Required: Strong technical knowledge of aseptic manufacturing techniques, procedures and theory. Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer. Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Strong analytical skills, documentation skills and research skills. Very strong problem-solving skills, ideally using formal tools e.g. FMEA. Strong understanding of pharmaceutical industry regulatory requirements. Clear understanding of the needs of cGMP and validation (DQ-PQ. DoE knowledge desirable. Knowledge of sterilization principles and practices. Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently. Strong team player. Good proactive approach & manner. Education Required : Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline. Further qualification (Masters) in related discipline preferred. Experience Required: At least 12 years relevant experience in a pharmaceutical manufacturing environment, with at least 6 years experience in a comparable process engineering/technical services role. Must have experience working in a sterile manufacturing environment. Ophthalmic manufacturing experience a plus. New facility start up experience desired. Equipment performance - cleaning validation, particle monitoring, thermal mapping. etc. Experience with many of the following processes: Product introduction and transfer. Cycle time and yield improvement initiatives. Continuous improvement projects. Equipment engineering runs, cycle development, PQ, Eng Runs, Media Fills and PV. Regulatory audit preparation and follow-up. Equipment and component specification. Component preparation – autoclaves, etc. Vial or bottle filling of sterile solutions. Cleaning (CIP/SIP) and sterilisation technologies. Isolator technology incl. VHP. Compounding – dispensing, formulation, sterile filtration, etc. Primary container closure components. Work Environment/Hazards and Physical Demands: The physical demands include those required of a normal office position and engineering shop floor support in a cleanroom environment. While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear. The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg. The employee is occasionally required to crouch. The employee is occasionally required to climb ladders to access technical areas. The employee must be capable of wearing sterile cleanroom garb in a grade B environment. The employee must be capable of wearing protective and/or safety equipment as needed. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel: The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time. However during the initial start-up phase of the manufacturing facility project, this may be as high as 30-50% for the first 12 months. Are you the one? Apply now by clicking the Apply button, or email Rebecca for more information –rebecca.brown@cpl.ie. Not ready to apply, or have some questions first? Call Rebecca on (01) 947-6212 to discuss in confidence! This job originally appeared on RecruitIreland.com.

2549 days ago