Sr Single Use Technology Applications Engineer

ROLE SUMMARY

 

The individual selected will be part of the Global Technology, Engineering & Launch group in the Single Use Network COE which delivers science-based solutions every day for every patient. 

 

Single-use systems are embedded in nearly every new biologic and sterile process, where assembly integrity, extractables/leachables risk, and process compatibility drive throughput, yield, and patient safety. This demands the ability to understand SUS at the material, mechanical, and process level; film and tubing behavior, weld and connector reliability, sterilization compatibility, fluid dynamics through complex assemblies.

This role will also define, develop, and deliver the streamlined, cleaner, greener SUS portfolio of the future. The SUN COE depends on this expert to qualify next-generation assemblies for launch pipelines, support supplier changes, and ensure supply continuity across the network.

 

This role will work with network partners, drug substance and sterile drug product process SME’s to understand the single use technology requirements, develop appropriate specifications, drive alignment and robustness of the portfolio with suppliers, and troubleshoot complex design and process issues. 

This position requires effective and direct communication skills, bold leadership and facilitation, and the ability to influence and integrate various colleagues from all levels of the organization.  

ROLE RESPONSIBILITIES

As a Single Use Technologies Applications Engineer your responsibilities could include:

Technical

• Global technical authority for single-use systems; assemblies, tubing, connectors, filters, and bioprocess containers

• Lead interface with manufacturing sites, suppliers, Quality, and GTEL DP teams for SUS deployment and life cycle support

• Owns SUS design standards, qualification strategies, fluid path assessments, process compatibility, and end-user technical requirements

• Deep knowledge of end-to-end SUS process from film and tubing extrusion through assembly, sterilization, and integration into Pfizer processes

• Provide advanced technical subject matter expertise and issue resolution for complex process designs and investigations across all business units

• Develop single use technology solutions for upstream, downstream, and final fill applications   

• Applies technical knowledge and project management skills to achieve goals of the department

• Ensure compliance with relevant regulations and guidance

• Write risk assessments and technical reports

• Evaluate innovative technologies to support key programs like NetZero and PFAS-free single use technologies that meet manufacturing process requirements

• Collaborating with analytical and small scale labs (e.g., Experimental Pilot Plant in Puurs) to execute exploratory or feasibility studies  

• Provide necessary technical inputs to develop AI and Digital solutions to enable enterprise process simplification

• undefined

Managerial

• Comfortable with multifunctional and multi-cultural environments. Effective influencer, motivator and communicator.

• Maintaining project updates in digital systems

• Influencing skills and ability to work in a matrix organization to deliver results

• Manage complex projects including defining scope, deliverables, and meeting tight timelines

• Knows when to report or escalate risks and issues to leadership and provides alternative approaches/solutions to mitigate these risks/issues   

 

Interpersonal Effectiveness

• Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all PGS stakeholders 

• Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, QA,  PharmSci, Procurement, and GCMC  

 

 

Approach / Mindset

• Recognizes cross-functional impact in all decision-making; proactively reaches out to external stakeholder groups to gain alignment on cross-functional issues

• Able to identify root causes and drive to problemresolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving

• Knows when to report or escalate risks and issues to leadership

• Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance

• Embraces Pfizer Purpose:  Breakthroughs that change patients’ lives through the incorporation of the Bold Moves and Values and Behaviour’s

QUALIFICATIONS

 

• Bachelors with at least 5+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience; MS preferred

• Operations or Tech services experience

• Experience in polymeric materials is a plus

• Green Belt experience is an advantage

• Knowledge of cGMP requirements and compliance

• Excellent communication and technical writing skills

• Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
• Ability to think creatively and find innovative solutions is a plus

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Global travel may be required, typically 10-15%.

• Adaptation of work schedule to accommodate meetings with colleagues in different time zones

• undefined

 
Work Location Assignment: Hybrid

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Engineering