Shift Process Engineer
- East
- Contract
- Life Sciences
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Shift Process Engineer.
This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.
Responsibilities:
- Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.
- Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Support continuous improvement through Lean Six Sigma methodologies.
- Leading and active participation in projects, system failure investigations and investigation reports,
- Execution/development of change controls to support the Process Simulation process
- Contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
- Implement subsequent corrective action through the change management system.
- Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
Drive compliance of Merck 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 in Carlow.
Requirements:
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Equipment and process validation7
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
- Experience in a Aseptic sterile manufacturing environment preferred
- Demonstrated ability to coach and lead change
- Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
If this interests you, please apply today!
#LI-CH3
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
Save as job alert
Similar Jobs
Salary
Competitive
Location
Carlow
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
East
Description
QC Microbiology Technician – Ireland – Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our
Reference
35192
Expiry Date
01/01/0001
Author
Christopher HutchinsonAuthor
Christopher HutchinsonSalary
Competitive
Location
Ohio
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
Central
Description
Senior Process Engineer – Ohio – Contract- Pharmaceutical This is a fantastic opportunity for a Senior Process Engineer to join our major, global pharmaceutical client on their latest
Reference
35201
Expiry Date
01/01/0001
Author
Annabel NangleAuthor
Annabel NangleSalary
Competitive
Location
County Dublin
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
Dublin
Description
MES Designer - Dublin, Ireland - 12-Month Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of MES Designer. A leader in the industry, our
Reference
34869
Expiry Date
01/01/0001
Author
Abigail StierAuthor
Abigail StierInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Christopher
I manage this role.