Senior Engineer
We are seeking a highly skilled and experienced Senior Engineer to join our team. This role involves independently providing and directing the characterization of process optimization strategies, troubleshooting operational issues, and contributing to major system modifications, experiments, and capital projects. The ideal candidate will apply advanced engineering principles and have a track record of successful problem-solving and technical project management in a regulated environment.
Responsibilities:
- Complete complex or novel assignments requiring innovative engineering techniques.
- Develop and implement engineering policies and procedures affecting multiple departments.
- Supervise, coordinate, and review the work of engineers, associates, and technicians.
- Apply advanced engineering techniques and principles within and beyond your discipline.
- Act as a recognized engineering specialist, determining methodologies for specialized areas.
- Plan and execute projects using mature engineering knowledge.
- Develop technical solutions to complex problems using creativity and ingenuity.
- Collaborate with cross-functional teams, including research, manufacturing, process development, utilities, and validation, to define system requirements and recommend facility modifications.
- Ensure projects meet schedule, budget, and quality constraints by working closely with project managers.
- Coordinate efforts with consultants, architects, and engineering firms to develop standard design documents.
- Develop and manage project budgets encompassing multiple disciplines or complete smaller projects independently.
Key skills:
- Experience with URS, DS, and Equipment Risk Assessments.
- Strong expertise in process characterization and validation, including:
- Protocol development and execution.
- Validation report preparation.
- Ability to independently determine and manage internal and external resources for problem-solving.
- Exceptional leadership and teamwork capabilities, including conflict resolution and collaboration.
- Effective verbal and technical presentation skills.
- Proficient in schedule development, facilitation, negotiation, and cost management.
- Advanced problem-solving and applied engineering.
- Technical and analytical expertise for process improvement.
- Personal organization and time management to handle multiple projects simultaneously.
- Leadership in managing contractors, vendors, and cross-functional teams.
- Demonstrated ability to develop creative and effective solutions to moderate-to-complex technical challenges.
Qualifications:
- Doctorate degree OR
- Master's degree with 3 years of engineering experience OR
- Bachelor's degree in Engineering with 5 years of engineering experience.
- Mechanical Engineering, Industrial Engineering, Chemical Engineering, or Electrical Engineering.
- Working knowledge of pharmaceutical/biotech processes.
- Familiarity with validation processes and documentation in regulated environments.
- Experience with device assembly and packaging equipment validation.
- Comprehensive understanding of GLPs and GMPs.
- Expertise in validation protocol execution, characterization, and reporting.
- Strong analytical problem-solving, technical writing, and project management skills.
- Proficiency in financial analysis tools and computer literacy.
- Specialized equipment/process expertise.
Shift:
- 8-hour shifts, 5 days a week
Average salary estimate
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Join our innovative team as a Senior Engineer and take your career to the next level! We are looking for a highly skilled individual who can independently drive process optimization strategies and tackle operational challenges with confidence. In this dynamic role, you'll harness your advanced engineering principles to contribute to significant system modifications, experiments, and capital projects. If you're someone who thrives on solving complex problems and enjoys technical project management within a regulated environment, this opportunity at our company is tailored just for you. As a Senior Engineer, you will have the chance to complete unique assignments requiring inventive engineering techniques and implement policies that span across multiple departments. Your leadership skills will shine as you supervise and review the work of engineers, associates, and technicians while coordinating with various teams to define system requirements and recommend necessary modifications. Additionally, you'll manage project budgets and schedules, ensuring all tasks meet quality standards and deadlines. If you hold an advanced degree in Mechanical, Industrial, Chemical, or Electrical Engineering, have a working knowledge of pharmaceutical and biotech processes, and can navigate validation protocols with ease, we can't wait to meet you. Come and be a part of our team where creativity and expertise come together to drive exceptional results!
to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.
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