Lead Bioprocess Associate

Desired Skills: GMP,Biotech,Production

PE Global is currently recruiting for a Lead Bioprocess Associate for a leading multi-national Biotech client based in Meath.

This is an initial 11-month contract position that requires flexibility to work on a 4 cycle shift pattern.

ROLE:

Lead/Guide team members to support on floor manufacturing of pipeline products on a shift rotation
Provide guidance, coaching and mentoring to the rest of the production team
Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
Conduct all work activities with a strict adherence to the safety and compliance culture on site
Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.
Lead, facilitate and participate daily in cross-functional teams to collaborative effectively to ensure compliance

REQUIREMENTS:

Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
Competent in troubleshooting and show practical problem-solving capabilities.
Ability to work independently and within a cross-functional team.
Understanding of multi column chromatography concepts
Familiarity with contamination control and batch release requirements
Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.  
Proficiency in various SingleUse technologies in a manufacturing environment
Problem, Deviation, and Change Management experience 
Commissioning and Qualification experience   
Experience of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge of key unit operations.
Understanding of both continuous and batch fed manufacturing processes  
Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits