Lead Clean Utilities & Process Engineer

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

The Lead Clean Utilities & Process Engineer reports into the Site Engineering Manager and will provide Technical Engineering support and oversight for Sparks Clean Utilities / Facilities and Supporting Processes. This role will primarily provide engineering support to Spark developing and executing new equipment / system implementations, future equipment / system modifications, process changes and development, continuous improvement activities or day to day troubleshooting as needed.

The Lead Clean Utilities & Process Engineer - will be responsible for the following key tasks:

• Technical engineering support for all engineering activities.
• Provide subject matter expertise support to spark operations and other departments.
• Support of large CAPEX projects and deliverables including process-oriented deliverables through Basic Design, Detailed Design, Execution and Operational phases of those projects.
• Provide subject matter expertise support to spark operations and other departments.
• Liaise with Spark MS&T and Process Engineering teams to support tech transfers, process optimizations / changes, and escalate process related deviations, CAPA’s and troubleshooting as needed.
• Organize and lead Clean Utilities and Process Equipment / System commissioning and qualification, including development and execution of any associated protocols and reports.
• Support the development and lifecycle management of Standard Operating Procedures (SOPs) and Logbooks for equipment / system set up and operation.
• Support the integration of SOPs, Master Batch Records (MBRs), and Logbooks into an electronic Manufacturing Execution System
• Create associated training materials and provide training for internal operations and maintenance teams.
• Provide direction and maintain the product / process lifecycle requirements for the commercial production Facility.
• Evaluate conceptual aspects of technical process designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.
• Meet scheduled milestones to ensure operations or project/program objectives are met in a timely manner.
• Collaborate with numerous teams within Spark (Manufacturing, Digital Systems, MS&T, R&T, AQC, Process Development, and Quality) to ensure all facility and process capabilities are delivered maintained and supported in accordance to Spark principles, policies and standards
• Support Development / Review / Approval of protocols, manufacturing and validation batch records. Ensure sampling and testing are completed as planned, executing manufacturing batch records and evaluate all in-process and analytical data, write reports as necessary.  Partners with MS&T, QA and Manufacturing Operations.
• Support cross functional teams in the coordination and execution of projects associated with alternate sources of raw materials, process development, product and process optimization batches, and on completion to ensure robustness of the process.
• Take part in process equipment / system specification, design and implementation.
• Identify changes to improve processes in a cGMP environment. Develop and implement process improvements through cross-functional interactions
• Provide Subject Matter Expert (SME) knowledge as required on process within the area of responsibility.
• Closely interact with Operations / Maintenance to develop, implement, and improve practices and procedures.
• Support the overall CQV process, in part by being the lead and SME for DRDQ and FCCA documentation, development and execution.
• Provide daily and direct process support to Spark operations.
• Lead investigations as applicable

Responsibilities

Provide day to day / routine technical process equipment / system operations and project support for Sparks Clean Utilities and Processes.

• Cross functionally collaborate with other engineering functions as needed for routine troubleshooting (Digital Systems, Process Engineering, etc.)
• Author / and Review deviations pertaining to Clean Utilities and processes and support product impact assessments for manufacturing process as applicable.
• Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for Spark Operations.
• Support reviews of any Manufacturing Change Controls, Validation protocols, and CAPAs, collaborate with operations teams on CAPA effectiveness.
• Manage on-time approval and closure of these quality records.

Site Engineering Core Team member responsible to support of activities related to the Clean Utilities and Process support functions aspects.

• Support the development, review and maintain lifecycle process documentation pertaining to manufacturing process platforms and perform impact / risk assessments to the facility, consumables, and raw material requirements.
• Own Clean Utility and Process equipment specification and design.
• Identify changes to improve processes 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
• Support the lifecycle Validation process, in part by being the site lead and SME for DRDQ and FCCA documentation, development and execution.
• Attend and execute equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and Spark site(s).

Act as a liaison between Spark Operations and MS&T, Process Engineering, Automation Engineering and Capital project teams for large CAPEX projects, tech transfers and process optimizations. 

• Support Large Capex Projects as Site Process Engineering
• Escalate complex issues to Global Process SME’s and MS&T for advanced support. 
• Participate as site process engineering support in analysis of process performance and development activities and studies as needed. 
• Support cross functional teams in analysis of technically sound single use process equipment / system 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/MS (MS preferred) Engineering degree in a relevant field or area of specialization (biochemical / mechanical / chemical engineering)
• Minimum of 8-10 years’ experience in cGMP Biotechnology or Pharmaceutical industry.
• Experience in biopharmaceutical based GMP manufacturing science and technology.
• Experience with Water Pre-treatment, Purified water, Water For Injection (WFI), Process gases (Clean Compressed Air, Oxygen, Nitrogen, etc.) and other raw materials
• Experience with Cleanroom Design
• Direct experience in gene therapy production environments.
• Experience with Single Use Technology (SUT) processes
• Up to 10% travel required
• Previous process equipment / system commissioning, qualification, validation experience
• Previous experience leading the DRDQ and FCCA efforts.
• Clean Utilities and Process equipment troubleshooting, testing, startup/turnover, lifecycle maintenance experience
• Experience with FDA, USP, ICH, EMA, ISPE
• Experience working within a BSL-2 environment.
• Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation. 
• Proven track record in cross functional collaboration and communication within 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 $118,800 to $178,200.