One of our valued clients in Dublin is looking to recruit Process Engineers with expereince of working in Sterile Environment on Drug produt or Drug Substance Projects
Role will involve the following .
· Design/Author/Review/Approve/Execute qualification documentation in line with the standard process.
· Leads experimental design of studies, execution, data analysis and interpretation. Authors and reviews batch documentation, regulatory and technical documentation
· Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
· Support the execution of development and PPQ batches, change control management and implementation
· Lead and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
· Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site. Serve as a key member during internal audits and external inspections/audits
· Lead and support various MS&T organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Must have change control experience
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
Must have knowledge and experience of upstream/downstream processing and process control strategies.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
Ability to effectively articulate understanding biologics processes, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
Job Type: Full-time
Pay: €30.00-€60.00 per hour

Application question(s):

• Have you worked on GMP-regulated projects in the pharmaceutical or biotech sector ?
• Have you supported previous PPQ Studies for NPI

Education:

• Bachelor’s (required)

Experience:

• upstream/downstream : 2 years (required)
• process control strategies : 2 years (required)
• GMP Sterile in Ireland: 2 years (required)

Work authorisation:

• Ireland (required)

Location:

• Swords, CO. Dublin (required)

Work Location: In perso

Please refer the Job description for details