Main Responsibilities
- Ensure seamless integration of automation systems with digital applications to support production, quality control, and data management.
- Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols, and system validation.
- Identify and proactively manage risks; ensure GMP compliance to minimize disruptions to timelines and costs.
- Develop and deliver specialized training materials; provide ongoing support post-implementation.
- Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer to capture and document detailed requirements.
- Develop standards and best practices for development and validation activities; lead design reviews and user acceptance testing during change/validation.
- Participate in facility operational meetings to meet reporting needs.
- Oversee daily monitoring, troubleshooting, and support of automation systems (PLCs, SCADA, DCS, and other control systems).
- Identify, propose, and implement process and system improvements to enhance automation performance, reduce costs, and improve manufacturing flexibility.
- Work with engineering, production, quality, IT, and other teams to align automation with production goals and regulatory requirements.
- Ensure all automation activities comply with GMP and safety standards; lead risk management for automation systems.
- Provide rotating on-call support during off-shift hours.
Qualifications / Requirements
- Bachelorโs degree in engineering or related technical field (Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, etc.).
- 2+ years direct experience in automation systems and automation support (biopharma or related preferred).
- Knowledge of process control systems (DCS/DeltaV, SCADA/Aveva, PLCs, and related technologies).
- Understanding of machine connectivity and data acquisition from PLCs into systems like Historian/ERPs using technologies such as OPC.
Soft Skills
- Ability to collaborate effectively cross-functionally.
- Analytical problem-solving skills.
- Effective communication with diverse stakeholders.
Language
- Proficiency in written and spoken English.
Benefits (as stated)
- Health and wellbeing benefits, high-quality healthcare, prevention and wellness programs, and at least 14 weeksโ gender-neutral parental leave.