We are seeking a highly skilled Senior Engineer to independently lead and support process optimization initiatives, troubleshooting activities, system modifications, validation efforts, and capital projects within a pharmaceutical/biotechnology manufacturing environment.
The Senior Engineer will apply advanced engineering principles to solve complex technical issues, support operational excellence, and lead engineering projects of significant scope and complexity. This role requires strong technical expertise, leadership capabilities, project coordination experience, and the ability to collaborate effectively across multiple functional areas.
The ideal candidate will possess experience in regulated manufacturing environments, including validation, change control, equipment support, and engineering project execution.
Key Responsibilities:
- Complete complex or novel engineering assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures impacting multiple organizational units.
- Supervise, coordinate, and review the work of engineers, associates, technicians, contractors, and vendors on both ongoing operations and project activities.
- Apply advanced engineering techniques and mature engineering knowledge to manufacturing, operations, pilot plant, and capital project environments.
- Serve as a subject matter expert in at least one engineering technology area.
- Support troubleshooting and root cause analysis for operational and process-related issues.
- Develop, organize, analyze, and present technical data, findings, recommendations, and project updates.
- Handle multiple projects, priorities, and assignments simultaneously in a fast-paced environment.
- Collaborate effectively with cross-functional teams including Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, Validation, and Research groups.
- Support vendor coordination, vendor escorting activities, and contractor management.
- Support purchase order (PO) creation and processing activities as required.
- Ensure compliance with cGMP, GLP, regulatory, safety, and company procedural requirements.
- Participate in change control, nonconformance investigations, CAPA activities, and validation initiatives.
- Perform additional duties as assigned.
- Develop technical solutions for complex engineering and operational challenges requiring creativity and innovation.
- Support design, implementation, and execution of system/facility modifications, equipment upgrades, and engineering projects.
- Work with project managers to ensure projects are completed within schedule, budget, and quality expectations.
- Coordinate consultants, contractors, architects, and engineering firms during development and execution of engineering projects.
- Develop departmental or project budgets for engineering initiatives.
- Assist with schedule development, project planning, completion, and follow-up activities.
- Provide technical leadership for validation protocol development and execution associated with new equipment installations and process improvements.
Technical Knowledge & Skills:
- Working knowledge of pharmaceutical and biotech manufacturing processes.
- Familiarity with validation processes and validation protocol execution requirements.
- Ability to interpret and apply GLPs, GMPs, and engineering standards.
- Ability to apply engineering science and analytical thinking to production and operational challenges.
- Strong analytical problem-solving and troubleshooting skills.
- Ability to independently identify when additional internal or external resources are needed.
- Ability to develop solutions for technical problems of moderate to high complexity.
- Technical report writing and technical presentations
- Project coordination and basic project management
- Schedule development and project follow-up
- Computer literacy and specialized equipment expertise
- Leadership and team building
- Negotiation, facilitation, and conflict resolution
- Contractor and vendor management
- Financial analysis and project cost development
- Collaboration across multiple communication and working styles
Requirements
- Doctorate degree in Engineering; OR
- Master’s degree in Engineering with 2+ years of engineering experience; OR
- Bachelor’s degree in Engineering with 4+ years of engineering experience.
Preferred Qualifications
- Experience within pharmaceutical or biotechnology manufacturing environments.
- Experience supporting parenteral products, vision systems, device assembly, and packaging operations.
- Strong technical writing and documentation experience.
- Working knowledge of cGMP procedures, engineering practices, manufacturing processes, facilities, and equipment.
- Experience with:
- Validation processes and protocol execution
- Change Control systems
- Nonconformance investigations
- Corrective and Preventive Actions (CAPA)
- QRAES
- Maximo
- Experience supporting vendors, contractors, and external resources.
- Experience working in highly regulated environments with strong documentation practices.
- Strong leadership, facilitation, collaboration, and conflict resolution skills.
- Independent, self-motivated, organized, and capable of managing multiple priorities simultaneously.
Benefits
- Shift: 1st Shift / Administrative Shift
- Contract position
