Senior Specialist, Engineering (Onsite)

About the role

The FLEx organization is seeking a highly motivated individual to serve the role of Senior Specialist, Technical Operations Engineer, reporting to the Technical Operations Engineering Lead. The successful candidate will support routine operations through timely troubleshooting and resolution of production equipment issues, establish new processes, and implement continuous improvement projects aimed at reducing operation cycle time, errors, and costs. This individual will collaborate closely with the Production, New Product Introduction, Facilities, Equipment, Automation, and Quality teams to ensure compliant, right-first-time execution and timely delivery of business goals.

Responsibilities

• Support routine operations through timely troubleshooting and resolution of production equipment issues.
• Establish new processes and implement continuous improvement projects.
• Collaborate with the Production, New Product Introduction, Facilities, Equipment, Automation, and Quality teams to ensure compliant, right-first-time execution and timely delivery of business goals.
• Occasionally cover second-shift operations to support the second-shift team during periods of absence.
• Occasionally support weekend operations based on business and operational needs.

Requirements

• Minimum Education: BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related engineering field with a minimum of 5 years of relevant experience.
• Experience and Skills:
  • Subject Matter Expertise in various sterile processing equipment such as automated filling lines, lyophilizers, autoclaves, part washers, isolators and etc.
  • Knowledge of automation systems such as PLC, DCS, and MES.
  • Knowledge of Drug Product aseptic processing techniques.
  • Experience in leading and supporting quality deviation investigations and change management.
  • Familiarity with United States and European Union GMP and Safety compliance regulations.
  • Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
  • Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.
  • Demonstrated project management experience leading cross-functional initiatives from planning through execution, with a proven ability to manage scope, timelines, risks, and stakeholder expectations.
  • Possess and leverage strong working knowledge of theories, practices, and procedures to train others efficiently. Apply knowledge to improve processes.
  • Familiarity with common Drug Product processing unit operations such as mixing, filtration, temperature control and etc.
  • Leverage Lean Six Sigma Green Belt certification.

Qualifications

• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Skills

• Experience providing technical mentorship to engineers and cross-functional team members, including guidance on problem-solving, project execution, and professional development.
• Experience with Commissioning, Qualification and Validation of equipment.
• Understanding of ISA88 and ISA95 principles.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Leverage Lean Six Sigma Black Belt certification.