JOB SUMMARY- Lead engineering activities on complex capital equipment projects ranging from $1-10 million, ensuring technical compliance with customer User Requirements Specifications (URS).
- Prepare Functional Specifications (FS) in accordance with contract documents; act as process owner for P&IDs to ensure equipment performance meets URS.
- Coordinate engineering activities to support project deliverables, including planning and tracking all engineering submittals.
- Work with Engineering Supervisors to define and plan project engineering tasks; serve as a key engineering representative on assigned projects.
- Communicate and coordinate engineering deliverables across all project team members.
- Approve engineering documents including P&IDs, GAs, FRS, HDS, block diagrams, P&ID/electrical schematic cross-checks, FV, EV, P&IDV, and safety sections of manual sets.
- Chair internal design reviews in accordance with the Project & Quality Plan (PQP).
- Control the Interface Control Document (ICD) to ensure proper integration with loading systems.
- Prepare traceability matrices for GAMP compliance.
- Interface with customers to resolve design-related technical issues for freeze dryers; manage control and release of proprietary information.
- Prepare test protocols per URS and lead resolution of process-related issues during testing to ensure equipment performance requirements are met.
- Identify scope creep and support the Project Manager in analyzing cost and schedule impacts.
- Support departmental projects, standards development, and best-practice initiatives.
- Provide input to Engineering Supervisors for evaluation of department staff performance.
- Consistently observe and promote SHEQ requirements for self, department personnel, contractors, visitors, and guests.
This role requires extensive experience with freeze-drying equipment and lyophilization systems used in the pharmaceutical industry.
SKILLS AND EXPERIENCES- Bachelors degree required, with minimum 6 years of relevant engineering experience
- Strong organizational skills and ability to independently plan and manage workload.
- Experience in technical liaison and communication with internal departments, vendors, and customers (written and verbal).
- Computer skills adequate to support engineering responsibilities.
- Strong understanding of lyophilization processes and freeze-dryer manufacturing specifically on pharmaceutical lyophilization systems or freeze-drying machinery, preferred
WHAT WOULD MAKE YOU A GREAT FIT - Availability to work overtime as needed.
- Willingness to travel nationally and internationally as required.
- Flexibility to support additional departmental tasks and initiatives.
SALARY RANGEWHAT WE OFFER- GLOBAL ENVIRONMENT: A dynamic and innovation-driven workplace, part of a multinational and multicultural group.
- DIVERSITY & INCLUSION CULTURE: Promoted through the Corporate Code of Ethics and dedicated programs.
- CONTINUOUS LEARNING: We view learning as a strategic lever for growth and motivation. We support internal training and external development initiatives.
- WELLBEING: We offer comprehensive medical, dental, vision, life and disability insurance, a 401(k) retirement plan, and tuition assistance. As well as an annual bonus.
Country: US
City: Tonawanda (Buffalo Area)
Placement area: Engineering and R&D
