Overview
Supporting CAPEX and OPEX projects within the Life Science Industry.
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.
Responsibilities
* 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.
Qualifications
* Demonstrated leadership and change management skills with a continuous improvement focus.
* Proven track record of delivering high performance through development and coaching of a team.
* Evidence of continuous professional development.
* Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
Technical Skillset
* SME in upstream/downstream processing and process control strategies. Working knowledge of analytics.
* 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.
* Evidence of continuous professional development. Technical writing skills.
* 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.
How to Apply
Please submit your resume to james.haddington@nesfircroft.com
About NES Fircroft
NES Fircroft is the world\'s leading engineering staffing provider, with over 100 years of combined experience delivering workforce solutions. We are a people-focused business, and with over 105 offices in 85 different countries, we have access to the best talent wherever it may be in the world.
I focus on CapEx Projects across the life sciences industry, supporting industry-leading clients across Europe.
If this role doesn\'t sound of interest, but you are interested in hearing of other roles more aligned, reach out to me on james.haddington@nesfircroft.com.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Contract
* Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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