Downstream Bioprocess Associate

Morgan McKinley; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a Specialist, Downstream Manufacturing (Downstream Bioprocess Associate) to support ongoing manufacturing operations and related commissioning/qualification activities in a 24/7 facility in Ireland. The role involves collaboration with CQV, Automation/CSV teams and production groups to ensure compliant, efficient operations.

The ideal candidate will have Level 6 engineering/science qualifications with 1–3+ years in a biopharmaceutical manufacturing setting, and

Qualifications

• Bachelor-style level 6 or higher in Engineering/Science, or equivalent.
• 1–3+ years in a large-scale biopharmaceutical manufacturing facility.
• DeltaV and MES experience is advantageous.

Responsibilities

• Support commissioning and qualification activities for process equipment.
• Create operating procedures and documentation for large-scale manufacturing.
• Execute manufacturing processes according to approved work instructions.
• Adhere to cGMP and SOPs.
• Participate in investigations and optimisations using science, engineering and lean principles.
• Operate production equipment within the assigned area.
• Utilise process automation systems (DeltaV, Syncade, OSI/Pi Historian) and business systems (SAP, Trackwise, Maximo).
• Review batch and exception reports with Quality and input to investigations and QA audits.
• Contribute to continuous improvement and operational excellence.

Skills

Communication

Problem solving

Independent worker

Cross-functional teamwork

Education

Level 6 qualification (Engineering/Science)

Tools

DeltaV

MES

Job description

Job Description:

Our client is seeking to recruit a Specialist, Downstream Manufacturing (Downstream Bioprocess Associate) within the Manufacturing Operations group.

Reporting to the Senior Manager, Downstream Manufacturing Shift Lead, the Specialist, Downstream Manufacturing will support the ongoing manufacturing operations within the facility,

as well as commissioning and qualification activities for the process equipment where required.

This is a 24/7 shift role.

Key Duties and Responsibilities:

• Working with the manufacturing operations group, project design team, the CQV team, & the Automation/CSV reps to facilitate the implementation of the project design and validation of the MPCC manufacturing facility.


• Creation of operating procedures & other relevant documentation for large scale manufacturing


• Execution of commercial manufacturing processes according to established work instructions.


• Adheres to Good Manufacturing Practices and Standard Operating Procedures.


• Takes part in investigations and optimisations of processes using scientific, engineering and lean principles


• Operates all production equipment within the assigned functional area


• Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).


• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative and provide input to related investigations and QA audit activities.


• Engages in and supports culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and safe work environment.

Qualifications, Knowledge and Skills Required:

• The successful candidate will ideally possess a minimum of Level 6 qualification in an Engineering/Science related discipline; however, relevant experience in a similar regulated industry will also be considered (e.g. cGMP, ISO or similar cleanroom industry experience strongly preferred).


• Ideally possess 1-3+ years' working experience in a large-scale biopharmaceutical manufacturing facility


• Experience with Delta V and MES would be considered an advantage.


• The successful candidate must demonstrate an ability to work independently and also as part of a team.


• The successful candidate must demonstrate problem solving ability and to adhere to scheduled timelines.


• Excellent communication skills and the ability to work in a cross functional collaborative environment are required.