Job Description
My client a leading Pharmaceutical company now require a Senior Process Engineer to join their expanding team.
The Senior Process Engineer will play a key technical role in the new state of the art Biologics facility. The Process Engineer is responsible for engineering & validation support activities during the tech transfer and day-to-day operations at the Biologics facility. They will be responsible for ensuring that all engineering activities associated with tech transfer, manufacturing activities and associated projects are completed as per approved Standard Operating Procedures (SOP’s), Protocols and Batch Records in a safe manner and in compliance with current Good Manufacturing Practices (cGMP).
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Senior Process Engineer - Biologics
- Use a focused, technical, problem solving approach to meet and exceed on functional and site goals and objectives.
- Act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, validation activities, conducting and leading investigations
- Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility
- Partake in specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolution
- Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive team environment.
- As a key member of the start-up team on site play a key role in the commissioning and qualification and validations activities on site, acting as a lead end user for systems as they transition across to the operations teams. Ensure consistency between process design and technical SOPs
- Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
- Lead Best practice Aseptic Technique principles current with the GXP/ GMP guidelines
- Attend Seminars on Aseptic technique principles ensuring compliance to current GMP guidelines.
- Provides significant contributions on project teams and may lead multi-functional teams on large multi-site project.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Report to management on a regular basis on performance and report any issues that need to be resolved.
- Foster compliance and schedule adherence to ensure the operational plan is achieved, including
- Maximize the success rate for production operations by instituting programs to minimize failures. Support strategic plans for plant improvements in order to increase efficiency and drive down costs.
- Communicate plant operational status regularly to management at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
Requirements of Senior Process Engineer – Biologics :
- Bachelor’s degree in a technical discipline (Science or Engineering)
- >5 years’ experience in Aseptic filling operations and/or upstream biotechnology processes in a GMP environment.
- Experience with filling equipment and control approaches (e.g. RABS and isolator) preferred.
- Should be knowledgeable of regulatory and GMP requirements.
- Proven ability around working cross functionally, delivering technical solutions and identifying improvements.
- Experience working in a self-managed work team, embracing an interdependent working culture that delivers results
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below