Pharmaceutical Automation Engineer

Femtech Insider Ltd.; Mesa (AZ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Competitive salary & equity compensation

Unlimited PTO

Comprehensive health benefits

Job summary

Femtech Insider Ltd. is looking for an experienced Automation Engineer to develop and maintain automation systems in pharmaceutical manufacturing. You'll play a critical role in ensuring system reliability and compliance with FDA and GxP standards.

The ideal candidate will have a degree in Electrical Engineering with 3–5 years of experience in regulated environments. The position includes generous benefits like unlimited PTO and comprehensive health coverage.

Qualifications

• 3–5+ years of experience in regulated environments (pharmaceutical, biotech, etc.)
• Hands-on experience with BMS, EMS, SCADA platforms, and HMI development.
• Working knowledge of low-voltage infrastructure and VPN setup.

Responsibilities

• Design and implement automation control systems for BMS, EMS, and SCADA.
• Collaborate with IT for network security and remote login support.
• Ensure compliance with GxP, FDA, and cGMP standards.

Skills

Automation systems knowledge

Problem-solving skills

Communication skills

Cross-functional leadership

Regulatory compliance understanding

Education

Bachelor’s degree in Electrical Engineering or related field

Tools

BMS, EMS, SCADA platforms

PLC programming

AutoCAD

Job description

About the Role

We are seeking a skilled Automation Engineer to support the design, implementation, and maintenance of automation systems including Building Management Systems (BMS), Environmental Monitoring Systems (EMS), SCADA platforms, and HMI integration in pharmaceutical manufacturing and compounding environments. This role plays a critical part in ensuring system reliability, data integrity, and regulatory compliance across all facilities.

The ideal candidate will collaborate with cross-functional teams including IT, engineering, validation, and facilities, and will support secure remote access, system networking, and low-voltage infrastructure planning in coordination with internal and external stakeholders.

Responsibilities

System Design & Integration

Design and implement automation control systems for BMS, EMS, and SCADA to monitor critical parameters such as temperature, humidity, differential pressure, HVAC performance, and cleanroom controls.

Configure and integrate Human-Machine Interfaces (HMIs) for operator control and monitoring of pharmaceutical processes.

Develop and maintain functional specifications, logic diagrams, wiring schematics, and network architecture for automation systems.

IT & Network Coordination

Collaborate with IT teams to define requirements for low-voltage cabling, IP address allocation, network security, and VPN access to support remote login and system integration for facilities and cleanroom equipment.

Coordinate with cybersecurity stakeholders and risk management to ensure compliance with data integrity and system access standards (e.g., 21 CFR Part 11, GAMP 5).

System Support & Troubleshooting

Support installation, commissioning, and qualification of automation hardware and software systems.

Troubleshoot hardware and communication issues between PLCs, HMIs, sensors, and enterprise systems.

Maintain and update automation system backups, patch management logs, and system audit trails.

Compliance & Documentation

Ensure automation systems meet GxP, FDA, cGMP, and 21 CFR Part 11 compliance standards.

Prepare and maintain validation documentation (e.g., IQ/OQ protocols), URS, FRS, and SOPs related to automation systems.

Support internal and regulatory audits by providing technical documentation and system access logs.

Cross-functional Support

Interface with validation, QA, and facilities engineering teams to support ongoing system monitoring, alarms, alerts, and environmental excursion response.

Work with vendors and contractors during new system implementation or upgrades.

Qualifications

• Bachelor’s degree in Electrical Engineering, Automation, Computer Engineering, or a related technical field.
• 3–5+ years of experience working with automation systems in regulated environments (pharmaceutical, biotech, medical device, or cleanroom facilities).
• Hands‑on experience with BMS, EMS, SCADA platforms (like Ignition, Wonderware, Rockwell FactoryTalk but not limited to), and HMI development (e.g., Siemens, Allen‑Bradley, Schneider Electric).
• Working knowledge of low-voltage infrastructure, remote access setup (VPNs, firewalls), and industrial networking (Ethernet/IP, Modbus, OPC UA).
• Familiarity with PLC programming, alarm management, data historian integration, and audit trail review.
• Understanding of regulatory compliance requirements such as 21 CFR Part 11, cGMP, and GAMP 5.
• Strong analytical, problem‑solving, and communication skills with the ability to work independently and across cross‑functional teams.
• Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools.
• Excellent cross‑functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
• Willingness to travel as required for vendor FATs and document punch‑list items for correction.
• Hands‑on experience supporting 503A and/or 503B compounding operations, with working knowledge of pharmacy regulatory standards.
• Strong analytical and problem‑solving skills, with the ability to troubleshoot complex technical issues.
• Excellent written and verbal communication skills and the ability to work effectively across cross‑functional teams.

Benefits

• Competitive salary & equity compensation for full‑time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

EEO & Accessibility

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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