Senior Process Engineer:
Buffalo, NY area
You will be doing engineering activities on complex capital equipment projects, 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 (safety, health, environmental, & quality) for self, department personnel, contractors, visitors, and guests.
This role is designated as Senior Process Engineer and requires extensive experience with freeze-drying equipment in the pharmaceutical industry.
SKILLS AND EXPERIENCE
BS degree required, with minimum 6 years of related experience specifically on pharmaceutical freeze-drying machinery.
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.
Background check and drug test are required
Targeted salary range, $100k to $115k
