- BBBH752336 Dec 03, 2020 €50k - €70k
This is an exciting role for an ambitious Process Engineer to join a new sterile fill finish manufacturing site as it prepares to commence commercial supply to patients.
The Process Engineer is responsible for providing key technical and scientific support in the production of sterile drug products. As a member of the technical services team this technical and engineering support will focus on our bio-services manufacturing area, drug product compounding and sterile fill finish. Responsibilities will include driving process continuous improvement including yield performance, equipment & process reliability, process control and coordinating process troubleshooting and root cause analysis. The Process Engineer will report to the Technical Services Manager.
Essential Duties, Functions and Responsibilities:
- Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
- Is the process SME for the compounding and filling process and supports manufacturing and maintenance in ensuring the performance of these processes.
- Supports manufacturing by leading/supporting deviation investigations, and is familiar with structured problem solving and root cause analysis
- Supports validation activity in process manufacturing areas.
- Leads continuous improvement projects and initiatives and is owner of yield performance and cycle time improvement.
- Will provide technical support for the receiving site activities necessary for the successful transfer of new products onto the Athlone site via a structured and compliant NPI (new product introduction) process.
- Provides technical support for product APRs (Annual Product Review)
- Provides training and mentoring to build technical capabilities among teams.
- Supports capital projects throughout equipment lifecycle.
- Specific knowledge of pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
- Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
- 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.
- 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 with a proactive approach & manner
- Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
- Further qualification (Masters) in related discipline would be ideal.
- At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years experience in a comparable process engineering/technical services role.
- Ideal has experience working with aseptic manufacturing processes.
- Experience should include a number of the following processes/technologies:
- Vial or bottle filling of sterile solutions
- Compounding - dispensing, formulation, sterile filtration, etc.
- Isolator technology incl. VHP
- Cleaning (CIP/SIP) and sterilisation technologies
- Component preparation - autoclaves and parts washers.
- Primary container closure components
- Cycle time and yield improvement initiatives
- Continuous improvement projects
- Regulatory audit preparation and follow-up
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.
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.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
353 (0) 21 2300300