Senior Engineer
Senior / Staff Engineer – Process Optimization & Design Engineering
Position Summary
The Senior / Staff Engineer independently leads and supports complex engineering initiatives focused on process optimization, troubleshooting, and system improvements within manufacturing, operations, pilot plant, or capital project environments.
This role applies advanced engineering principles to design, implement, and evaluate system modifications, experiments, and large-scale projects. The position is responsible for interpreting data, developing technical solutions, and delivering high-impact results for complex engineering challenges in regulated environments.
Key Responsibilities
General Engineering
- Lead and execute complex or novel engineering assignments requiring the development of new or improved techniques and procedures.
- Develop and implement engineering policies and procedures impacting multiple organizational units.
- Supervise, coordinate, and review the work of engineers, technicians, and associates across projects.
- Apply advanced and cross-functional engineering knowledge to diverse assignments.
- Serve as a subject matter expert (SME) in at least one engineering discipline, defining methodologies and technical approaches.
- Plan, execute, and oversee engineering projects using sound technical judgment and experience.
- Analyze, interpret, and present data for operational issues and projects of significant scope and complexity.
Design Engineering & Project Execution
- Develop innovative technical solutions to complex engineering problems requiring creativity and ingenuity.
- Collaborate with cross-functional teams including Manufacturing, Process Development, Quality Assurance, Validation, Facilities, and Utilities.
- Support and execute large-scale system or facility modifications, ensuring compliance with quality and regulatory standards.
- Partner with Project Managers to deliver projects within scope, schedule, budget, and quality expectations.
- Coordinate external resources including consultants, architects, and engineering firms.
- Develop and manage departmental or project budgets across multiple disciplines.
Qualifications
- Doctorate in Engineering, OR
- Master’s Degree in Engineering + 2 years of experience, OR
- Bachelor’s Degree in Engineering + 4 years of experience
Required Skills & Competencies
Technical & Regulatory
- Strong knowledge of pharmaceutical or biotechnology manufacturing processes
- Experience working in highly regulated environments (cGMP / GLP)
- Familiarity with validation lifecycle, including protocol development and execution (IQ/OQ/PQ)
- Knowledge of documentation practices aligned with regulatory standards (e.g., ALCOA+)
- Ability to apply engineering science to production and process improvements
- Experience with specialized laboratory or manufacturing equipment
Engineering & Problem Solving
- Advanced analytical and problem-solving skills using scientific and engineering principles
- Ability to develop solutions for technical challenges of moderate to high complexity
- Experience in process troubleshooting and optimization
- Strong technical writing and reporting capabilities
Project & Leadership Skills
- Ability to manage multiple projects simultaneously
- Basic to intermediate project management skills (planning, scheduling, execution, follow-up)
- Experience delegating tasks and managing technical teams
- Ability to identify when additional internal or external resources are required
- Experience managing contractors and vendors
Communication & Collaboration
- Strong verbal and written communication skills
- Ability to work effectively across diverse teams and communication styles
- Skills in negotiation, facilitation, and conflict resolution
- Strong collaboration and stakeholder management abilities
Additional Competencies
- Financial and budget management awareness
- Technical presentation and documentation skills
- Organizational and time management skills
- Established expertise in multiple engineering disciplines
Preferred Qualifications
- Experience in aseptic manufacturing environments
- Hands-on experience with Fill/Finish operations (vials, syringes, or similar systems)
- Experience supporting New Product Introductions (NPI)
- Experience in process characterization and Performance Qualification (PQ) activities