Job Description
The Senior Engineer independently leads and/or directs process optimization, troubleshooting, and engineering project execution within manufacturing, operations, pilot plant, or capital project environments.
This role applies advanced engineering principles to design, implement, and optimize complex systems, processes, and facility modifications. The engineer is responsible for developing, analyzing, and presenting data-driven solutions for issues and projects of significant scope and complexity, while serving as a technical subject matter expert in at least one engineering discipline.
Key Responsibilities
- Lead complex and novel assignments requiring development of new or improved engineering techniques and procedures.
- Develop and implement engineering policies and procedures impacting multiple functional areas.
- Supervise, coordinate, and review the work of engineers, associates, and technicians.
- Apply advanced and cross-disciplinary engineering principles to solve complex problems.
- Serve as a recognized subject matter expert (SME) in a specialized technical area.
- Plan and execute engineering projects using sound technical judgment and methodologies.
- Lead characterization studies and process optimization initiatives.
- Troubleshoot operational issues in manufacturing, pilot plant, and production environments.
- Develop innovative solutions using data analysis, engineering theory, and experimentation.
- Interpret and present complex technical data to support decision-making.
- Develop technical solutions for complex system and facility challenges requiring creativity and ingenuity.
- Collaborate with cross-functional teams (Manufacturing, Process Development, Quality, Validation, Facilities, Utilities).
- Define requirements and provide recommendations for large-scale system or facility modifications.
- Support execution of capital projects within scope, schedule, budget, and quality constraints.
- Coordinate external consultants, contractors, architects, and engineering firms.
- Develop and manage project budgets across multiple disciplines.
- Support and ensure compliance with validation processes (IQ/OQ/PQ).
- Contribute to validation protocol development and execution.
- Ensure adherence to GMP, GLP, and regulatory requirements.
- Maintain and review technical documentation in a regulated environment.
- Lead cross-functional teams and engineering initiatives.
- Manage multiple projects simultaneously, ensuring timely delivery.
- Delegate tasks and oversee execution of project deliverables.
- Manage contractors, vendors, and external resources.
- Support financial planning, cost estimation, and project tracking.
Required Skills
- Strong knowledge of pharmaceutical/biotech manufacturing processes.
- Working knowledge of validation lifecycle (IQ/OQ/PQ).
- Familiarity with GMP/GLP regulations and documentation practices.
- Advanced problem-solving and analytical engineering skills.
- Ability to apply engineering principles to production environments.
- Strong technical writing, reporting, and presentation skills.
- Effective verbal communication and cross-functional collaboration.
- Ability to manage multiple projects and priorities simultaneously.
- Proficiency in standard computer and engineering tools.
Requirements
- Master’s degree + 2 years of Engineering experience, OR
- Bachelor’s degree in Engineering + 4 years of Engineering experience
Preferred Qualifications
- Degree in Mechanical or Chemical Engineering
- Experience in aseptic manufacturing environments
- Hands-on experience with Fill/Finish operations (vial and syringe filling lines).
- Experience supporting:
- Process characterization studies
- Performance Qualification (PQ) activities
- New Product Introductions (NPI)
- Strong experience in capital projects, system design, and equipment installation.
- Demonstrated ability to lead complex engineering projects in regulated environments.
- Experience coordinating contractors, vendors, and multidisciplinary teams.
Benefits
- Administrative Shift &.Non-Standard Shift
- 8-month contract
