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Job Description

We are seeking a Process Engineer to support a leading pharmaceutical company. This candidate will support the Biologics INnovation Xceleration (BioNX) facility at Dunboyne. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The BioNX Facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.

As a member of the Manufacturing Technologies and Engineering group, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next-generation technologies to keep our company at the forefront of innovation in the development and manufacturing of biologics.

Key Responsibilities:

Develop Standard Work Templates:

Create and implement Leading Standard Work Templates for new technologies, equipment, and product integration.

Ensure templates adhere to industry best practices and support streamlined operations.

Data Analysis & Visualization:

Collect and analyze raw project data to generate actionable insights.

Develop visualizations that communicate key performance indicators and drive informed decision-making.

Translate complex data into compelling user stories for cross-functional teams.

Critical Path Optimization:

Identify bottlenecks and redundant actions within project workflows.

Optimize the critical path to accelerate project delivery.

Design and implement process improvements that enhance efficiency and reduce waste.

Cross-Functional Collaboration:

Work closely with project managers, R&D teams, and digital transformation experts.

Drive continuous improvement initiatives by integrating feedback and data-driven insights.

Ensure that process enhancements align with overall project objectives and timelines.

What you will do:

o Participate in the planning, coordination, and implementation of next generation technologies being implemented in Batch and Continuous Manufacturing by leading and supporting the:

o Transfer of platform technologies from the earlier pipeline facilities, and bringing to GMP status locally.

o Transfer of platform technologies to future commercial facilities.

o Partnering within a cross-functional team to implement new technologies / software / instruments that can simplify and reduce effort around manufacturing and administrative processes, sharing with network counterparts.

o Supporting troubleshooting and act as SME for manufacturing technology.

Aggregate process related knowledge, and centralize for knowledge management. Support the area's implementation of process changes, and root cause investigation of deviations.

Support Weekend or On Call duty on select time frames to support manufacturing during new technology introduction.

Own life cycle development and qualification from initiation through implementation of methods / recipes for automated equipment, integrating into the overall site DeltaV System.

Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.

Embody Safe by Choice know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Bachelors degree in Process Engineering, Chemical Engineering, or a related field.

6+ years of process engineering experience in the pharmaceutical, biotech, or life sciences industries.

Expert in tech transfer of large molecule drug substance and product

Proven track record in creating and implementing leading standard work templates and process improvements.

Demonstrated experience in optimizing project workflows and critical paths.

Proficiency in data analysis and visualization tools (e.g., Power BI, Tableau, Excel).

Familiarity with digital tools and project management software.

Strong analytical skills with the ability to develop actionable user stories from raw data.

Demonstrated experience in optimizing project workflows and critical paths.

Knowledge of resource loading and capacity planning techniques. Advanced degree (Masters or PhD) in a related field.

Certification in Lean, Six Sigma, or other process improvement methodologies. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].