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 unlock the power of gene therapy to accelerate healthcare transformation.

We don’t follow footsteps. We create the path.

Primary Duties

Reporting to the Director of Engineering & FEED, the Site Engineering Automation & Infrastructure Lead will provide technical support to Spark’s Corporate, Technical and Scientific Facilities which include cGMP Manufacturing, Research and Technology (R&T) and corporate IT / Office spaces focused on facility / building systems (Building Automation System (BAS), Environmental Monitoring System (EMS)) and associated Infrastructure / Instrumentation and controls.

This role will primarily provide engineering support to Spark developing design and executing new system implementations (Including design, construction, start-up, commissioning, qualification and routine operational activities), future system modifications, supporting large and small CAPEX projects, continuous improvement activities, advanced day to day troubleshooting and operational support as needed.

The Site Engineering Automation and Infrastructure Lead - will be responsible for the following key tasks:

• As System Owner, provide routine technical day to day support of the Site / Facility systems (BAS / EMS), infrastructure, instrumentation and associated controls for all of Spark’s sites.
• Routinely collaborate with other Engineering Disciplines, Facilities / Maintenance, Manufacturing Operations, Digital Systems, Process Automation, IT and other departments within the R&T organization to implement and complete activities related Facilities Automation Systems and controls design, construction, start-up and commissioning activities for capital projects.
• Ensure that engineering design and maintenance strategy, consider loss elimination and risk management.
• Provide Subject Matter Expertise (SME)
  • Evaluate conceptual aspects of technical BAS / EMS, facility infrastructure and associated control designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance.
  • Challenge internal design and/or external supplier technical data, recommendations, and operability to ensure Reliability, Maintainability, and Availability minimum requirement targets are met.
• As the system owner, support large CAPEX projects and deliverables through Basic Design, Detailed Design, Execution and Operational phases of those projects. Meet scheduled milestones to ensure operations or project/program objectives are met in a timely manner.
• Liaise with other Spark Engineering departments, Facilities/Maintenance and Operations teams to support site optimizations / changes, tech transfers, CAPA’s or quality related changes, root cause investigations and advanced troubleshooting as needed.
• Organize and lead commissioning, including development and execution of any associated protocols and reports as system owner.
• Own lifecycle maintenance of BAS / EMS, Facility infrastructure and associated instrumentation and controls engineering drawings, documentation, specifications (Master, Technical, Design etc.), standards and reports.
• Support the development and lifecycle management of Standard Operating Procedures (SOPs), BOMS and Preventative Maintenance Plans for equipment / system set up and operation.
• Create associated training materials and provide training for internal operations and maintenance team as needed.
• Support the overall Validation process, in part by being the system owner and lead SME for DRDQ, FCCA, and Validation protocol development and execution.
• Lead investigations as applicable.
• Other duties as assigned.

Responsibilities

Provide day to day / routine support and lifecycle maintenance.

• Cross functionally collaborate with other engineering functions as needed for routine troubleshooting (Digital Systems, Clean Utilities, Mechanical & HVAC etc.)
• Author / and Review deviations pertaining to BAS / EMS and support impact assessments for Sparks Site / Facilities as applicable.
• Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for Spark Scientific, Technical and Manufacturing Operations.
• Support reviews of any Change Controls, Validation protocols, and CAPAs. Collaborate with operations teams on CAPA effectiveness.
• Manage on-time approval and closure of these quality records.
• Own Lifecycle for associated Engineering Records, drawings, specifications, standards

Site Engineering Core Team member responsible for EMS / BMS, Facility infrastructure, and associated Instrumentation and controls.

• Act as system owner for BAS / EMS, facility infrastructure and associated controls specification and design.
• Identify changes to improve design in a cGMP environment.
• Own Small CAPEX projects, develop and implement process improvements / optimizations or continuous improvements.
• Provide Subject Matter Expert (SME) knowledge as required on process within the area of responsibility.
• Own commissioning for area’s of responsibility.
• Support the lifecycle Validation process, in part by being the site lead and SME for DRDQ and FCCA documentation, development and execution.
• Support and attend facility equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and Spark site(s).

Large CAPEX projects, tech transfers, Site / Facility optimizations and evaluation.

• Support Large Capex Projects as system owner for area of responsibility.
• Support cross functional teams in analysis of Site / Facility design concepts, methods and standards to be implemented at site.
• Provide support to Regulatory for authoring relevant sections of submissions and to Quality for deviation investigations, CAPAs and change controls.
• Manage contract and internal resources to execute site related capex projects ranging up to $10MM in accordance with site priorities and company initiatives / goals.

Education and Experience Requirements

• BS or MS Engineering degree in a relevant field or area of specialization (Electrical / Mechanical engineering Etc.)
• Minimum of 15 years’ experience in cGMP Biotechnology, pharmaceutical or equivalent Engineering Service oriented industry.
• Applied automation design engineering and project engineering is required.
• Development / lifecycle maintenance of engineering records, standards, spec’s and drawings.
• Previous commissioning, qualification, validation, troubleshooting, testing, startup, turnover and lifecycle maintenance.
• Experience in GCP/GLP/GMP environments including direct engineering design development / deployment / support of BAS, EMS, other Facility Infrastructure systems / tools preferred.
• Experience supporting / organizing and delivering applications from concept to go-live in an operational facility environment.
• Knowledge of IT/OT Infrastructure, shop floor devices, facility control systems, data historians.
• Knowledge of GXP compliance and experience with Data Integrity elements.
• Up to 10% travel required.
• Experience with FDA, USP, ICH, EMA, ISPE.
• Demonstrated knowledge of International Society of Automation (ISA) Standards.
• Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
• Testing, troubleshooting, and integration of Environmental Monitoring System (EMS) platforms, Building Automation System (BAS) platforms. (Siemens Disego, Vaisala Viewlinc a plus).
• Proven track record in a CAPEX program environment.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $147,500 to $221,300.

Nearest Major Market: Philadelphia