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Process Engineer - Operations
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineering, Engineer
Projektbeschreibung
ROLE: PROCESS ENGINEER - MULTIPLE
LOCATION - IRELAND, CO. CARLOW
TYPE - INITIALLY 6 MONTH CONTRACT
SUMMARY:
Responsible for providing process, technical, and validation support including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required. The role is based within the Technical Engineering function.
KEY RESPONSIBILITIES:
- Support Production investigations and author production investigations in line with site procedures and regulatory expectations
- Perform CAPA, CC & troubleshooting to support production.
- Support Operations through batch release activities including but not limited to EBR & batch Pack Review and track to closure as required.
- Participate and lead improvement initiatives in Operations
- Complete Impact assessments to support site investigations and site Change Controls.
- Present on production deviations and production documentation through Regulatory inspections
- Support Site Inspection Readiness Activities and present Operations Deviations, Processes and Procedures in Regulatory Inspections
- Deliver training on operations compliance systems and outcomes of investigations/improvement Projects as required
- Develop as an MES Super user on site and support production troubleshooting and investigations
- Support continuous improvement through Lean Six Sigma methodologies.
- Lead and actively participation in projects, system failure investigations and investigation reports,
- Contribution to Lean events including Kaizen' or PDCA' as required.
- Identify and deliver on deviation
- Note: Role may require transition to a shift pattern.
- 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.
- Work collaboratively to drive a safe and compliant culture.
KEY REQUIREMENTS:
- Bachelor's Degree or higher preferred -ideally in a Science, Engineering or other Technical discipline
- Relevant experience and a particular skill set in their area of expertise that adds value to the business ideally in pharmaceutical manufacturing, preferably in a GMP setting
LOCATION - IRELAND, CO. CARLOW
TYPE - INITIALLY 6 MONTH CONTRACT
SUMMARY:
Responsible for providing process, technical, and validation support including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required. The role is based within the Technical Engineering function.
KEY RESPONSIBILITIES:
- Support Production investigations and author production investigations in line with site procedures and regulatory expectations
- Perform CAPA, CC & troubleshooting to support production.
- Support Operations through batch release activities including but not limited to EBR & batch Pack Review and track to closure as required.
- Participate and lead improvement initiatives in Operations
- Complete Impact assessments to support site investigations and site Change Controls.
- Present on production deviations and production documentation through Regulatory inspections
- Support Site Inspection Readiness Activities and present Operations Deviations, Processes and Procedures in Regulatory Inspections
- Deliver training on operations compliance systems and outcomes of investigations/improvement Projects as required
- Develop as an MES Super user on site and support production troubleshooting and investigations
- Support continuous improvement through Lean Six Sigma methodologies.
- Lead and actively participation in projects, system failure investigations and investigation reports,
- Contribution to Lean events including Kaizen' or PDCA' as required.
- Identify and deliver on deviation
- Note: Role may require transition to a shift pattern.
- 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.
- Work collaboratively to drive a safe and compliant culture.
KEY REQUIREMENTS:
- Bachelor's Degree or higher preferred -ideally in a Science, Engineering or other Technical discipline
- Relevant experience and a particular skill set in their area of expertise that adds value to the business ideally in pharmaceutical manufacturing, preferably in a GMP setting
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges