MS&T Process Engineer

PE Global is recruiting for a MS&T Process Engineer for our biopharmaceutical industry client in Dublin. This is an initial 11-month contract, hybrid role.

The MS&T Process Engineer delivers a range of technical support to the Drug Substance Business: leading technical investigations within the Integrated Process Team, supporting significant projects across the site, supporting design, construction and qualification of upstream & downstream equipment (when applicable), NPI/technology transfer and commercialization. The MS&T Process Engineer ensures that MS&T team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers, while creating an inclusive culture that energizes a Safety First, Quality Always, continuous improvement mindset.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• 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.
• 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 multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.
• 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.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
• Experience leading technical related projects.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience in preparing for and presenting in front of regulatory audits as SME.
• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organization for development and/or manufacturing.
• Experience in change management, deviations and CAPAs management.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***