Orion Group Life Sciences are currently recruiting a Process Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.
Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing with a particular focus on automated visual inspection, The ideal candidate will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other appropriate working environments.
Knowledge of process monitoring systems, automation systems, operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
Role Functions
Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
Design/Author/Review/Approve/Execute Execution/development of change controls
Contribution to Kaizen events as appropriate
Technical input into quality notification by authoring/reviewing/approving investigations
Execution of equipment/qualification validation programs; including re-qualification and re-validation
Support continuous improvement through Lean Six Sigma methodologies
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums
Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
Experience/Qualifications
Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
Preferably Min 2 years' experience ideally in manufacturing, preferably GMP Setting
Demonstratable experience of leading technical related projects
Previous experience with Automated visual inspection systems is desired, but not essential.
Evidence of continuous professional development is desirable
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Report, standards, policy writing skills required
Equipment and process validation
Sterile filling processes and equipment
Proficiency in Microsoft Office and job-related computer applications required
Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
