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.
As GTIC site approaches operational readiness this role will transition to a site operational support 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.
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.
- Support C&Q execution for automation systems.
- Participate in SLIA and FCCA.
- Lead DRDQ.
- Review C&Q 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.
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.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- BS or MS Engineering degree (mechanical, chemical, or related field)
- Applied automation design engineering and project engineering is required.
- Project management experience preferred.
- 8 – 10 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.
Complexity and Problem Solving
- 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
Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
- 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.
Frequent internal and external contacts. Represents Site Automation Engineering organization specific projects.
Other Job Requirements
- 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
- 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.
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