The Senior Process Engineer reports into the Gene Therapy Innovation Center (GTIC) Engineering Leader and will provide technical support for the GTIC site processes, program, and unit operations for the manufacturing operations team. This role will primarily provide process engineering support to the manufacturing operations team developing and executing future equipment / system modifications, process changes and development, continuous improvement activities or day to day troubleshooting as needed.
This position will also provide process support on the commercial production facility process and operational requirements (Both Upstream and Downstream), evaluate conceptual / detailed aspects of technical process designs to ensure sound decisions, practices and investments are made in accordance with business strategy and internal policy/governance and assess new innovative process / single use technologies to be implemented in accordance with the established commercial platforms.
The GTIC Senior Process Engineer - will be responsible for the following key tasks:
- Technical process engineering support for all site manufacturing activities.
- Support of large CAPEX projects and deliverables including process-oriented deliverables through Basic Design, Detailed Design, Execution and Operational phases of those projects.
- Own small CAPEX process-oriented projects and deliverables in accordance with GTIC site goals and initiatives.
- Communicate effectively amongst a multitude of internal and external cross functional teams.
- Provide subject matter expertise support to manufacturing operations and other departments.
- Liaise with Spark MS&T and Global Process Engineering teams to support tech transfers, process optimizations / changes, and escalate process related deviations, CAPA’s and troubleshooting as needed.
- Support and execute the manufacturing operations strategy as developed by organizational leadership
- Organize and lead 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 and external sites of manufacturing
- 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 the Spark Technology Development Organization (Manufacturing, Digital Systems, Automation Engineering, Facilities Engineering, MS&T, 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 manufacturing projects associated with alternate sources of raw materials, process development, product and process optimization batches, and on completion to ensure robustness of the process
- Write and Review documents pertaining to manufacturing process platforms and perform impact assessments to process, consumables, and raw material requirements.
- Participate in development and lifecycle maintenance of technically sound single use process equipment / system concepts. 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 manufacturing operations.
- Support Manufacturing operations and author / technically support manufacturing deviations, CAPAs, and change controls.
- Lead investigations as applicable
- Other duties as assigned.
The GTIC facility is currently being designed and built. GTIC Senior Process Engineer will provide direct support to / under the GTIC Project Process Engineering Team Lead in driving the associated design, construction, commissioning, DRDQ, FCCA and start up activities for the materials, equipment / systems, and operational readiness needs and requirements for the GTIC project until the site becomes operational.
% of Time
Job Function and Description
Provide day to day / routine technical process equipment / system operations and project support for the Manufacturing Operations Team at the GTIC facility.
- Cross functionally collaborate with other site engineering disciplines as needed for routine troubleshooting (Automation engineering, Facilities engineering etc…)
- Author / and Review deviations pertaining to manufacturing processes and support product impact assessments for manufacturing process as applicable.
- Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for GMP Manufacturing operations.
- Support reviews of any Manufacturing Change Controls, Validation protocols, and CAPAs, collaborate with Manufacturing operations team on CAPA effectiveness.
- Manage on-time approval and closure of these quality records.
Primary duties will be for GTIC project support as noted above into operational readiness.
Site Operations Core Team member responsible to support of activities related to the process 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.
- Take part in 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 manufacturing site.
Act as a liaison between GTIC site operations and the MS&T, Global 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.
Education and Experience Requirements
- Manage contract and internal resources to execute site related capex projects ranging up to $10MM in accordance with site priorities and company initiatives / goals.
Key Skills, Abilities, and Competencies
- BS/MS (MS preferred) Engineering degree in a relevant field or area of specialization (biochemical / mechanical / chemical engineering)
- Minimum of 12 years’ experience in cGMP Biotechnology or Pharmaceutical industry.
- Experience in biopharmaceutical based GMP manufacturing science and technology.
- Direct experience in gene therapy, cell culture and/or purification (downstream) in development and/or production environments.
- Extensive experience with Single Use Technology (SUT) processes
- Up to 10% travel required
- Previous cGMP batch documentation authoring and lifecycle management experience
- Previous process equipment / system commissioning, qualification, validation experience
- Previous experience leading the DRDQ and FCCA efforts.
- Previous electronic manufacturing systems creation or management
- Process equipment troubleshooting, testing, startup/turnover, lifecycle maintenance experience
- The position requires knowledge and experience with cGMP manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
- 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
- Strong ability to manage time and balance multiple priorities
- Proven cross-functional collaborator
- Excellent oral and written communication skills
Complexity and Problem Solving
- Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution.
- Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
- 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
- Experience with data analytic tools such as SAS JMP a plus.
Internal and External Contacts
- 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.
- Manufacturing Operations Team
- Automation Engineering Team
- Facilities Engineering Team
- Manufacturing Sciences and Technology Team (MS&T)
- Global Process Engineering team
- 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
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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