What are the responsibilities and job description for the Engineering SME position at Eliquent Life Sciences, Inc?
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
The Engineering Subject Matter Expert (SME) plays a critical role in bridging advanced engineering principles with pharmaceutical manufacturing processes to ensure efficient, compliant, and innovative production operations. This position is responsible for providing expert guidance on the design, implementation, and optimization of pharmaceutical equipment and manufacturing workflows, leveraging deep knowledge of architectural design software and industry best practices. The SME collaborates closely with cross-functional teams including production, quality assurance, and R&D to drive continuous improvement and troubleshoot complex technical challenges. By integrating engineering expertise with regulatory and safety standards, the SME ensures that manufacturing processes meet stringent quality and compliance requirements. Ultimately, this role contributes to the successful delivery of high-quality pharmaceutical products while supporting scalable and sustainable manufacturing solutions across the organization.
Minimum Qualifications:
- Bachelor’s degree in Engineering, Pharmaceutical Engineering, or a related technical field.
- Proven experience with architectural design software relevant to manufacturing facility planning.
- Demonstrated knowledge of pharmaceutical manufacturing processes and equipment operation.
- Strong understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
- Excellent problem-solving skills and ability to communicate complex technical information clearly.
Preferred Qualifications:
- Master’s degree in Engineering or related discipline.
- Experience working within a pharmaceutical manufacturing environment.
- Certification in project management or process improvement methodologies (e.g., Six Sigma).
- Familiarity with automation and control systems used in pharmaceutical production.
- Previous experience in cross-functional team leadership or training roles.
Responsibilities:
- Lead the design and review of pharmaceutical manufacturing equipment layouts and facility architectural plans using advanced design software.
- Provide technical expertise and support for the operation and maintenance of pharmaceutical manufacturing equipment to optimize performance and reliability.
- Collaborate with manufacturing, quality, and regulatory teams to ensure processes comply with industry standards and regulatory requirements.
- Analyze and troubleshoot engineering issues related to pharmaceutical production processes, recommending and implementing effective solutions.
- Develop and deliver training and documentation to internal teams on best practices for equipment operation and process optimization.
Skills:
The required skills in architectural design software enable the SME to create and modify detailed facility and equipment layouts that optimize manufacturing flow and compliance. Expertise in pharmaceutical equipment operation allows the SME to provide hands-on guidance and troubleshooting to ensure equipment functions at peak efficiency. Knowledge of pharmaceutical manufacturing processes is essential for understanding the end-to-end production lifecycle and identifying opportunities for process improvements. Preferred skills such as project management and automation knowledge enhance the SME’s ability to lead initiatives that improve operational efficiency and integrate new technologies. Daily work involves applying these skills collaboratively to solve complex engineering challenges, support regulatory compliance, and drive continuous improvement in manufacturing operations.