Chief Engineer
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.
Cookordination engineering activities to support project deliverables, including planning and tracking all engineering submittals.
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.
Skills And Experiences
- BS degree required, with minimum 6 years of related experience specifically on pharmaceutical lyophilization systems or 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-drying manufacturing.
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 RANGE
$82,000 - $115,000
Bonus
What 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.