Job Description

REQUIRED SKILLS AND EXPERIENCE:

• BS Engineering degree in a relevant field or area of specialization (Electrical / Mechanical engineering Etc.)
• Minimum of 7 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, specs 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
• Knowledge of IT/OT Infrastructure, shop floor devices, facility control systems, data historians.
• Knowledge of GXP compliance and experience with Data Integrity elements.
• Testing, troubleshooting, and integration of Environmental Monitoring System (EMS) platforms, Building Automation System (BAS), Rockwell PLC, OS PI Historian platforms.
• Experience in Siemens Desigo BAS, Vaisala ViewLinc EMS, Rockwell ControLogix PLC a plus.
• Knowledgeable with drawing deliverables including schematic wiring diagrams, instrumentation loop diagrams, P&ID, AF&ID, control panel layouts and electrical single line diagrams.
• Knowledgeable with automation computer hardware and software including Microsoft operating systems, software drivers and communication protocols including Microsoft OS, Virtual Machine, PLC ladder logic, S88, OLE DB, SQL, OPC, ODBC, BACNET, MODBUS, Ethernet/IP etc.
• Proven track record in a CAPEX program environment

JOB DESCRIPTION:

Key Responsibilities:

• Project Oversight: Serve as the engineering representative for the GTIC project.
• Ensure the delivery of BAS and EMS systems aligns with project requirements and approved design criteria.

Collaboration:

• Work closely with various engineering disciplines, including Facilities/Maintenance, Manufacturing Operations, Digital Systems, Process Automation, Information Technology, and other departments within the project organization.
• Coordinate with system owners, construction engineers, managers, vendors, and startup teams to maintain project schedules.
• Engineering Design & Execution: Review and approve engineering submittals from vendors and contractors to ensure alignment with project specifications and approved designs.
• Review mechanical drawings, P&IDs, and specifications, identifying discrepancies and providing resolutions.
• Respond to Requests for Information (RFIs) to ensure clarity and accuracy in engineering documentation.
• Support detailed design reviews and risk assessments, ensuring all automation systems meet GMP, FDA, and Spark Therapeutics’ standards.

System Startup, Commissioning, and Qualification:

• Participate in the submittal review/approval process, construction coordination, system startup, commissioning, and qualification.
• Assist CQV with system startup, commissioning, and qualification of systems, and coordinate supplier/vendor and CQV document development.
• Perform routine site construction walkdowns to observe and document safety compliance, design compliance, track installation progress, and develop punch lists.
• Actively participate in mechanical completion walkdowns and follow up on the closure of punch items recorded.

Testing and Documentation:

• Support and attend facility equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and client sites.
• Support the development and lifecycle management of GTIC BAS and EMS Standard Operating Procedures (SOPs), BOMs, and Preventative Maintenance Plans for equipment/system setup and operation.
• Review P&IDs, loop drawings, wiring diagrams, technical specifications, and calibration records.
• Execute and document infield verification and resolve any discrepancies.
• Maintain and organize a tracker for identified discrepancies and issues, driving them to resolution to ensure minimal impact on project timelines.

Compliance, Documentation, and Reporting:

• Maintain detailed records of project progress, vendor interactions, qualification protocols, deviations, and corrective actions.
• Assist in the development and revision of SOPs related to equipment/system operation, maintenance, and qualification.
• Provide regular status updates to project teams and leadership, highlighting risks, challenges, and mitigation strategies.

Technical Skills and Qualifications:

• Automation Systems: Proficiency in BAS, EMS, and I&C systems, including design, implementation, and troubleshooting.
• Engineering Software: Experience with engineering software such as AutoCAD, Revit, and PLC programming tools.
• Instrumentation and Controls: Knowledge of instrumentation and control systems, including sensors, actuators, PLCs, SCADA systems, and DCS.
• Regulatory Compliance: Familiarity with GMP, FDA regulations, and industry standards for automation systems in a regulated environment.
• Technical Documentation: Ability to review and interpret technical documents, including P&IDs, loop diagrams, wiring schematics, and technical specifications.
• Project Management: Strong project management skills, including scheduling, resource allocation, and risk management.
• Problem-Solving: Technical troubleshooting and resolution skills for BAS/EMS system challenges during startup, commissioning, and qualification.
• Communication: Excellent communication skills to collaborate effectively with cross-functional teams, vendors, and stakeholders.

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