We are seeking experienced Operations Subject Matter Experts (SMEs) to support a major DeltaV automation implementation within a biopharmaceutical manufacturing facility. This role will serve as the primary Operations representative embedded within Agile sprint teams, ensuring manufacturing processes, batch execution requirements, operator workflows, and facility operations are accurately translated into the new Emerson DeltaV control system.
This is an excellent opportunity for manufacturing professionals with strong Drug Substance, API, or biopharmaceutical operations experience who want to play a key role in a large-scale automation and digital transformation project.
Key Responsibilities:- Agile Sprint Team Participation
- Act as the Operations representative within DeltaV software development sprint teams.
- Participate in daily stand-ups, sprint planning, backlog grooming, and sprint reviews.
- Provide operational input regarding equipment utilization, operator workflows, and manufacturing processes.
- Communicate project progress and gather feedback from Operations stakeholders.
- Process & Recipe Expertise
- Translate existing manufacturing processes and operating procedures into DeltaV functional requirements.
- Interpret batch records, electronic batch records (EBRs), recipes, and operating sequences.
- Support development of control modules, phases, sequences, and equipment modules.
- Provide input on operator graphics, navigation, and user interface design.
- Design Review & Testing Support
- Review functional design specifications, software requirements, SOPs, and test documentation.
- Support FAT, DSAT, commissioning, sequence testing, and integrated system testing activities.
- Identify operational gaps, process risks, and improvement opportunities.
- Collaborate with Engineering, Automation, CQV, Quality, and Manufacturing teams.
- Safety & Operational Excellence
- Provide expertise on operator access, alarm management, interlocks, and abnormal situation handling.
- Participate in PHA, LOPA, CHAZOP, safety reviews, and system handover activities.
- Support development of procedures and operator training materials to ensure successful startup and transition to the new control system.
Required Qualifications:- Significant hands-on experience in biopharmaceutical Drug Substance, API, or SDI operations.
- Strong understanding of manufacturing process equipment, utility systems, and facility operations.
- Experience with batch records, EBRs, recipe execution, or recipe development.
- Knowledge of legacy process control systems or distributed control systems (DCS).
- Experience working within GMP-regulated manufacturing environments.
- Commercial manufacturing or commercial supply experience.
- Strong communication skills with the ability to translate operational requirements to technical teams.
Preferred Qualifications:- Emerson DeltaV experience or exposure to DeltaV migration projects.
- Experience supporting automation, commissioning, qualification, FAT, or SAT activities.
- Familiarity with Agile, Scrum, or Kanban project environments.
- Experience reviewing FDS, SRS, and validation documentation.
Ideal BackgroundsCandidates may have experience in roles such as:- Operations SME
- Manufacturing Specialist
- Senior Manufacturing Associate
- Process Specialist
- Drug Substance Operator
- API Manufacturing Specialist
- Manufacturing Operations Lead
- Bioprocess Specialist
- DeltaV End User
- Process Technician
- Manufacturing Subject Matter Expert
