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Process Engineer 1

ID
14516
Location
Carlow
Role Type
Contract
Contact
Diarmuid Lannon
Email
consulting@hero.ie
Phone
+353 86 1287246
LinkedIn
click here

Process Engineer 1

Similar Jobs

Process Engineer

Location: Carlow,
Duration: 11 Months
Contract Type: Fixed Term Contract
Remote Role: No

Reporting to the Technical Engineering Manager, this role provides technical support for commercial manufacturing, focusing on commercial product processes. The successful candidate will participate in and/or lead cross-functional teams and will liaise with vendors and above-site groups. Candidates with prior related work experience in manufacturing, preferably in a GMP setting, are preferred, though other appropriate environments will also be considered.

Key Responsibilities

  • Documentation and Process Development: Design, author, review, approve, and execute qualification/validation documentation and process development studies.
  • Change Controls: Develop and execute change controls.
  • Kaizen Events: Contribute to Kaizen events.
  • Quality Notifications: Provide technical input by authoring, reviewing, and approving investigations.
  • Equipment Qualification/Validation: Execute equipment qualification and validation programs, including re-qualification and re-validation.
  • Continuous Improvement: Support continuous improvement through Lean Six Sigma methodologies.
  • Root Cause Analysis: Perform root cause analysis of system failures and substandard performance using standard tools and methods.
  • Technical Representation: Serve as a technical engineering representative for internal discussions and global technical forums.
  • Compliance: Ensure compliance with global policies, procedures, guidelines, and regulatory requirements. Execute current Good Manufacturing Practices (cGMP) and participate in audits and inspections.
  • Safety and Compliance Culture: Collaborate to drive a safe and compliant culture in Carlow.
  • Additional Duties: Perform other duties as assigned.

Experience, Knowledge & Skills

  • Demonstrable experience in leading technical projects.
  • Previous experience with sterile manufacturing is desired but not essential.
  • Evidence of continuous professional development is desirable.
  • Knowledge of process monitoring systems, automation systems (DeltaV), and operational intelligence & data systems (Pi System) within a GMP manufacturing environment is beneficial but not essential.
  • Understanding of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Skills in report, standards, and policy writing.
  • Experience with equipment and process validation.
  • Familiarity with sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications.
  • Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner.

Qualifications & Education

  • Bachelor’s Degree or higher in a Science, Engineering, or other Technical discipline is preferred.
  • Minimum 2 years of experience in manufacturing, preferably in a GMP setting.

For further information on this role in Galway, please contact Diarmuid Lannon on +353 861287246 or email consulting@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

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