Senior Automation Engineer

Employer
Spark Therapeutics
Location
San Francisco, California
Salary
Salary not provided
Closing date
May 28, 2022

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This role will report into the GTIC Engineering Leader under the Site Engineering Operations organization. The GTIC Senior Automation Engineer will provide technical automation support to Spark’s Gene Therapy Innovation Center (GTIC) which includes cGMP commercial manufacturing operations and related support functions. This role will collaborate and partner with the key stakeholders, including Manufacturing Operations, Site Process Engineering, Site Facility Engineering, MS&T, Global Automation Engineering Quality and IT.

The GTIC Senior Automation Engineer will:

  • Own and provide routine technical day to day support of the site automated process and facility systems (Process Automation System, Building Automation System, Environmental Monitoring System) and associated infrastructure at the GTIC facility.
  • Routinely collaborate with GTIC Facility Engineering, Maintenance, Manufacturing Operations, GTIC Process Engineering, IT and other departments within the Technical Development and Operations organization to implement and complete activities related to Process Equipment / Systems, Facilities Systems and Infrastructure design, construction, start-up and commissioning activities for capital projects.
  • Liaise with Spark Global Automation Engineering & Digital systems teams to support digital strategy implementation, tech transfers, automation system optimizations / changes, and escalate automation related deviations, CAPA’s and troubleshooting as needed.
  • Support large CAPEX projects and deliverables including automation-oriented deliverables through Basic Design, Detailed Design, Execution and Operational phases of those projects.
  • Own small CAPEX automation-oriented projects and deliverables in accordance with GTIC site goals and initiatives.
  • Directly interface with third party vendors and OEM’s to deliver on all projects and provide direct support during initial startup and operation of process or facilities systems and equipment.
  • Communicate effectively amongst a multitude of internal and external cross functional teams.
  • Provide subject matter expertise support to manufacturing operations and other site related functions and departments.
  • Support and execute the manufacturing operations and overall digital strategy as developed by organizational leadership.
  • Organize and lead automation equipment / system commissioning and qualification, including development and execution of any associated protocols and reports for necessary changes.
  • Support the development and lifecycle management of Standard Operating Procedures (SOPs) for equipment / system set up and operation as they are impacted by the digital / automated systems.
  • Support the integration of SOPs, Master Batch Records (MBRs), and Logbooks into an electronic Manufacturing Execution System.
  • 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 automation within the area of responsibility.
  • Provide daily and direct automation support to manufacturing operations, facilities and QC departments.
  • Support Manufacturing operations and author / technically support deviations, CAPAs, and change controls as they are applicable to site automation / digital systems.
  • Lead investigations as applicable
  • Other duties as assigned.


Note: The GTIC facility is currently being designed and built. GTIC Senior Automation Engineer will provide direct support to / under the GTIC Project Automation Engineering Team Lead in driving the associated specifications, design, construction, commissioning, validation and start up activities for all automated equipment / systems for the GTIC project until the site becomes operational.

Responsibilities

% of Time

Job Function and Description

(Interim Project Support)
Support as a Technical Automation Engineering SME on a strategic project. As an SME the Automation Engineer is considered an expert in the concept, design and fabrication, commissioning, and qualification of process automation systems in a cGMP environment.
  • Interpreting process and manufacturing requirements as developed by MS&T and the Project Process Engineering team.
  • Review process flow diagrams, mass balances, and process descriptions including critical process parameters provided by MS&T. Determine thoroughness to proceed with engineering design.
  • Responsible to understand the process requirements and how they impact the equipment design.
  • Responsible for developing preliminary and basic engineer deliverables that meet URS and compliance requirements, including best practices and guidelines. Depending on the project, some deliverables may be generated internally while at other times by external engineering.
  • Accountable for technical quality of design. Perform appropriate reviews with stakeholders.
  • Ensure engineering contractor calculations are correct and review vendor designs for adherence to specifications.
  • Responsible for delivering design that meets project budget and schedule.
  • Provide technical guidance to wider engineering team. Apply lessons learned from other sites and industry partners to improve troubleshooting.

Note: As GTIC site approaches operational readiness this role will transition to a site engineering operations role for automation / digital systems and engineering design implemented for the commercial production facility. The GTIC Senior Automation Engineer will provide direct support to / under the GTIC Project Automation Engineering Team Lead during the project.

55%
Provide day to day / routine technical automation / digital system operations and project support for the operations teams (Manufacturing Operations, Site Facilities Engineering, Site Process Engineering) at the GTIC facility.
  • Cross functionally collaborate with other site engineering disciplines as needed for routine troubleshooting (Process engineering, Facilities engineering etc…)
  • Author / and Review deviations pertaining to cGMP operations.
  • Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for cGMP operations.
  • Support reviews of any Change Controls, Validation protocols, and CAPAs, collaborate with GTIC operations teams on CAPA effectiveness.
  • Manage on-time approval and closure of these quality records.
  • Responsible to develop, adhere to, and understand GTIC site specific automation standards and procedures.

20%
  • Support CQV execution for automation and digital systems.
  • Participate in SLIA and FCCA.
  • Lead DRDQ
  • Review and support the development of CQV test plans for technical content.
  • Support automation completion and start-up.
  • Participate and lead automation equipment / system Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and manufacturing site.
  • Directly support CQV execution and testing.

15%
Act as a liaison between GTIC site operations, the Global Automation Engineering & digital Systems SME’s, MS&T and Capital project teams for large CAPEX projects, tech transfers and automation & digital system implementations, optimizations or changes.
  • Support Large Capex Projects as Site Process Engineering
  • Escalate complex issues and troubleshooting to Global Automation SME’s and MS&T for advanced support.
  • Participate as site automation engineering support in analysis of process performance and development activities and studies as needed.
  • Support cross functional teams / global SME’s in the development and implementation at site of a scalable, responsive, adaptive Plant Floor/OT landscape to enable the overall Technology Strategy and overall Integrated GXP Systems Architecture.
  • Contribute lessons learned to the Spark network. Participate in global initiatives. Responsible to understand current global design guidelines and application.

10%
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 (mechanical, chemical, or related field)
  • Applied automation design engineering and project engineering is required.
  • Project management experience preferred.
  • 10 – 15 years-experience; preferred pharmaceutical biotech industry experience
  • Must have demonstrated experience in engineering design/support involving the design, construction and commissioning of manufacturing and support equipment for the GMP processing of pharmaceutical materials.
  • Experience in pharmaceutical biotech based GCP/GLP/GMP environments including direct engineering experience in developing/deploying/supporting MES, DCS, BMS, EMS, Robotics, and other Plant Floor/OT systems/tools in a cGMP Environment preferred.
  • Experience supporting / organizing and delivering applications from concept to go-live in a real plant manufacturing environment.
  • Knowledge of GXP compliance and experience with Data Integrity elements of the various systems.
Key Skills, Abilities, and Competencies
  • Experienced in project engineering activities, including but not limited to, RFI review, submittal review, change request processes, scope/budget/schedule review, etc.
  • Testing, troubleshooting, and integration of Process Control System (PCS) platforms, Environmental Monitoring System (EMS) platforms, Building Automation System (BAS) platforms and Batch control platforms.
  • Facility infrastructure and manufacturing process equipment / system troubleshooting, testing, and startup / turnover experience
  • Well-developed skills in prioritization, organization, and time management
  • Highly motivated and detail oriented
  • Possess the ability to work independently and in a team environment with moderate supervision
  • Possess the ability to communicate vertically within an organization
  • Ability to effectively lead cross functional teams.
  • Up to 10% travel required
Complexity and Problem Solving
  • Efficiently complete true root cause analysis, corrective action plan development and execution, including effectiveness verification.
  • Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
  • Ensure resolution to all organizational, technical and product lifecycle management issues.
  • Works on complex problems where analysis of situations or data requires evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met.
  • Builds productive relationships internally and externally.
  • Frequent contacts with peers and vendors concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives, as needed.
Internal and External Contacts
Frequent internal and external contacts. Represents Site Automation Engineering organization specific projects.
  • Manufacturing Operations Team
  • Global Automation Engineering Team
  • Site Facilities Engineering Team
  • Site Process Engineering team
  • Manufacturing Sciences and Technology Team (MS&T)
  • Analytical Sciences, QA, QC, RA CM, PMO, CQV Functions.
  • Cross functional interactions with external A/E firm partners and GTIC Project team
  • Infrequent cross functional interactions internally with Process Development
  • Infrequent cross functional interactions with external CDMO and CMO organizations
Other Job Requirements
  • Requirement to work some weekends and off hours, depending on project schedules

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

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.

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