Biopharma DeltaV Operations Specialist

WorkLLama; Elkton (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

WorkLLama seeks an experienced Operations SME to support a major DeltaV automation implementation at a biopharmaceutical manufacturing facility. The role embeds within Agile sprint teams to translate manufacturing processes, batch execution requirements, operator workflows, and facility operations into DeltaV functional needs.

The ideal candidate has significant Drug Substance, API, or biopharmaceutical operations experience and will drive digital transformation across engineering, CQV, quality,

Qualifications

• Significant hands-on experience in biopharmaceutical Drug Substance, API, or SDI operations.
• Strong understanding of manufacturing process equipment, utility systems, and facility operations.

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.
• 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.
• 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.
• 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.

Job description

WorkLLama seeks an experienced Operations SME to support a major DeltaV automation implementation at a biopharmaceutical manufacturing facility. The role embeds within Agile sprint teams to translate manufacturing processes, batch execution requirements, operator workflows, and facility operations into DeltaV functional needs.

The ideal candidate has significant Drug Substance, API, or biopharmaceutical operations experience and will drive digital transformation across engineering, CQV, quality,