Engineering Lead
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
We don’t follow footsteps. We create the path.
Primary Duties
- Reporting to the Facilities Leader, the Engineering Lead will provide engineering technical support for Spark’s manufacturing (commercial, clinical, and pre-clinical) and associated laboratory equipment, facilities and process equipment.
- He/she will work closely and collaborate with Research and Development Operations, Business Administration, Corporate Facilities and other departments within Technical Operations to finalize expansion site selection, design, construction, start-up and qualification activities.
- Incumbent will support process equipment optimization activities required to improve product quality, reducing operating costs, increasing capacity, throughput, and productivity.
- The Engineering Lead may have people/team management responsibilities as the organization continues to grow and evolve.
Responsibilities
- Provide technical equipment and project expertise for the support of manufacturing equipment/facilities/processes including all phases of support from soliciting quotes, issuance of recommendations, design stage development, equipment fabrication, qualification, validation, building integration, equipment modifications.
- Ensure reliability for critical manufacturing equipment, compliance with internal and external site safety standards, GMP compliance for the facility infrastructure and robust delivery of facility lifecycle management through interface with outsourced maintenance providers and key business partners.
- Supports daily R&D, Manufacturing and Labs operations, including troubleshooting of utilities, equipment and systems to ensure the robustness of processes.
- Oversees and maintains engineering/project drawing files, that includes drawings, documentation (paper and electronic files) and other engineering records.
- Establishes and supports development of code requirements, basic design criteria and engineering specifications. Coordinates across functions, departments, construction and plant personnel.
- Hires, manages performance and develops direct reports; ensures departmental goals and objectives are aligned to functional and corporate goals and objectives.
- Manages other projects as assigned.
Education and Experience Requirements
- BS degree in an engineering-related field is required. An advanced degree is preferred.
- A minimum of ten (10) years of experience within the pharmaceutical/biotechnology industry is required; with minimum of five (5) years process engineering experience.
- Experience with aseptic (Grade A) operations is a plus.
- Experience with clean room designs is a plus.
- Experience working in a LEAN environment with tools such as Six Sigma is a plus.
- Must have demonstrated experience in project engineering involving the design, construction and qualification of manufacturing and support equipment for the GMP processing of pharmaceutical materials.
- Direct experience with Regulatory Inspections is preferred.
- Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines required.
Key Skills, Abilities, and Competencies
- Experience working in a GMP environment is required
- Possess the ability to multitask and work independently or in a team environment with moderate supervision
- Possess good interpersonal and strong written/verbal communication skills
- Well developed skills in prioritizing, organization and time management
- Highly motivated and detail oriented with good organizational skills
- Understanding of statistical analysis methods
- Minimal travel requirements such as factor acceptance testing
- Requirement to work some weekends and off hours, depending on project schedules