Domain: Pharmaceuticals / Biotechnology / Clinical Research
Experience Required: 715 years
Work Authorization: US Citizen / Green Card Holder / H1B Transfer / TN Visa / OPT EAD
Position Summary:
The Automation and Controls Engineer will play a pivotal role in maintaining upgrading and optimizing automated systems and process controls across Rising Pharmas manufacturing facility. You will lead key engineering projects support compliance with FDA regulations and collaborate crossfunctionally to drive operational excellence and ensure high system reliability.
Key Responsibilities:
Lead engineering design maintenance and installation of automated process facility and software systems
Troubleshoot and optimize PLCs SCADA systems HMIs and electromechanical equipment (AllenBradley essential)
Plan schedule and manage control system upgrade projects aligned with FDA and industry compliance
Support validation and metrology teams in equipment qualification per CSV (Computerized System Validation) standards
Ensure documentation aligns with cGMP and regulatory compliance (change controls CAPA SOPs deviations)
Utilize AutoCAD Windows systems and BMRAM software for engineering design and diagnostics
Collaborate with all departments to improve automation reliability reduce downtime and streamline data collection
Maintain excellent crossfunctional communication and complete all documentation to GMP standards
Required Qualifications:
Bachelors Degree in Electrical Engineering Software Engineering or related field with equivalent experience
Minimum 7 years of handson experience in automation and controls in a pharmaceutical manufacturing setting
Expertise in AllenBradley PLCs and HMI/SCADA system programming
Strong knowledge of 21 CFR Part 11GAMP 5 and FDAcompliant automation
Familiarity with QMS systems especially around SOPs deviations CAPA and change controls
Proven project leadership in upgrading control systems (PLC/SCADA/HMI)
Experience with Building Management Systems (BMS) and process utilities
Comfortable working onsite across shifts with some potential overtime or oncall responsibilities
Nice To Have Qualifications:
Experience with Siemens and B&R automation systems
Familiarity with OSI PIDeltaV and data acquisition tools
Prior exposure to robotic systems VFDs (e.g. Siemens G120 and highvoltage troubleshooting
Compensation:
Competitive Salary
Full health coverage: medical dental vision
Short/Long Term Disability
100 401K match up to 4
PTO 8 paid holidays
Health Savings Plans
Life Insurance for employees and family
Relocation assistance available (casebycase basis)
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