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This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$60.00/hr - $65.00/hr
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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 experience.
- Development and lifecycle maintenance of engineering records, standards, specs, and drawings.
- Experience in commissioning, qualification, validation, troubleshooting, testing, startup, turnover, and lifecycle maintenance.
- Experience in GCP/GLP/GMP environments, including direct engineering design, development, deployment, and support of BAS, EMS, and other facility infrastructure systems/tools.
- Knowledge of IT/OT infrastructure, shop floor devices, facility control systems, and data historians.
- Understanding of GXP compliance and Data Integrity elements.
- Experience with testing, troubleshooting, and integration of EMS, BAS, Rockwell PLC, OS PI Historian platforms.
- Knowledge of Siemens Desigo BAS, Vaisala ViewLinc EMS, Rockwell ControlLogix PLC is a plus.
- Familiarity with drawing deliverables like schematic wiring diagrams, P&ID, AF&ID, control panel layouts, and electrical single line diagrams.
- Proficiency with automation hardware/software, including Microsoft OS, PLC ladder logic, S88, OPC, 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 BAS and EMS systems delivery aligns with project requirements and design criteria.
- Collaborate with Facilities, Manufacturing, Digital Systems, IT, and other departments.
- Coordinate with system owners, vendors, and startup teams to maintain schedules.
- Review and approve engineering submittals, mechanical drawings, P&IDs, specifications, and RFIs.
- Support design reviews and risk assessments to meet GMP, FDA, and company standards.
System Startup, Commissioning, and Qualification:
- Participate in review/approval, construction, startup, commissioning, and qualification processes.
- Assist CQV with startup, commissioning, and qualification documentation.
- Conduct site walkdowns for safety, design compliance, and installation tracking.
- Participate in mechanical completion walkdowns and follow-up on punch list items.
Testing and Documentation:
- Support factory and site acceptance testing (FAT/SAT).
- Develop and manage SOPs, BOMs, and preventive maintenance plans.
- Review technical diagrams and calibration records; verify in-field.
- Track issues and ensure timely resolution.
Compliance, Documentation, and Reporting:
- Maintain detailed project records, qualification protocols, deviations, and corrective actions.
- Develop and revise SOPs related to equipment and system operations.
- Provide status updates, highlighting risks and mitigation strategies.
Technical Skills and Qualifications:
- Proficiency in BAS, EMS, and I&C systems, including design and troubleshooting.
- Experience with AutoCAD, Revit, PLC programming tools.
- Knowledge of instrumentation, sensors, actuators, SCADA, DCS.
- Understanding of GMP, FDA regulations, and industry standards.
- Ability to interpret P&IDs, wiring diagrams, and technical specs.
- Strong project management and problem-solving skills.
- Excellent communication skills for cross-functional collaboration.
Seniority level
Employment type
Job function
- Pharmaceutical Manufacturing
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Inferred benefits:
Medical insurance, Vision insurance, 401(k)
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