Operational Specialist

TALENT Software Services; Elkton (VA); On-site; USD 140,000 - 190,000; Full time

Job summary

TALENT Software Services is seeking a Sprint Operations SME with deep biopharmaceutical manufacturing and DeltaV experience. You will bridge software development and plant reality, translating legacy processes into DeltaV configurations and supporting design reviews, testing, and commissioning.

You will collaborate within an Agile team to ensure safe, compliant operations and a smooth facility startup, contributing to hazard analyses and interlock philosophy as needed.

Qualifications

• Significant hands-on experience in biopharmaceutical drug substance and SDI operations.
• Strong familiarity with legacy API/SDI control system functionality and translating operations to engineering terms.
• Experience creating and executing recipes, batch sheets/EBRs, and designing operational sequences.
• Experience navigating commercial supply phases of biopharmaceutical manufacturing with GMP/regulatory awareness.
• Excellent communication; translating complex procedures between operations and automation teams.

Responsibilities

• Integrate with Agile sprint teams; participate in daily stand-ups, planning, backlog grooming, and demos.
• Translate legacy processes into DeltaV requirements for design, configuration, graphics, and equipment modules.
• Review and approve design documents, assist with FAT/DSAT testing, and support commissioning and validation activities.
• Contribute to operator access, alarm/interlock philosophy, and safety reviews (PHA/LOPA) during development.

Skills

Operational expertise

Legacy system knowledge

Recipe management

Biopharmaceutical manufacturing

Communication & collaboration

Tools

Emerson DeltaV

Job description

The Sprint Operations SME will provide dedicated shop-floor, process operations, and recipe expertise to the Sprint team during the DeltaV software development, testing, and commissioning phases. Working within an Agile/Sprint team structure, this role bridges the gap between software development and daily manufacturing reality.

The successful candidate will ensure that the new Emerson DeltaV automation solution being installed as part of the Fastnet project accurately reflects current and future manufacturing requirements, supports safe and compliant operations, and enables a robust, seamless facility start up.

Key Responsibilities

• 1. Agile Sprint Team Integration & Collaboration

  Active Sprint Participation: Serve as the core Operations representative within DeltaV software development sprint teams, participating in daily stand-ups, sprint planning, backlog grooming, and sprint demonstrations.

  Operational Feedback: Provide immediate, practical feedback on process operations, equipment utilization, operator workflows, and physical facility constraints to the development team.

  Peer Communication: Act as the primary liaison between the automation development team and the wider Fastnet Operations team translating technical progress and gathering feedback as required.

• 2. Operational Translation & Requirement Definition

  Legacy-to-DeltaV Translation: Translate existing *** DCS functionality, operating practices, and tacit operational knowledge into clear, actionable requirements for DeltaV functional design, configuration, graphics, and equipment modules.

  Recipe & Batch Sheet Interpretation: Utilize deep manufacturing and recipe knowledge to interpret batch sheets/EBRs and operational needs, converting them into optimized DeltaV phases, recipes, control modules, and sequential operations.

  Graphics Input: Inform the design of intuitive operator interfaces, control graphics, and navigation paths to ensure ease of use, minimize human error, and streamline physical operator workflows.

• 3. Design Review, Testing, and Commissioning Support

  Document Review & Approval: Review and approve Functional Design Specifications (FDS), Software Requirement Specifications (SRS), design documents, test scripts, and Standard Operating Procedures (SOPs) to ensure operational accuracy.

  Testing Execution Support: Support software design reviews, sprint demonstrations, internal design reviews, Software Factory Acceptance Testing (FAT), Developer System Acceptance Testing (DSAT), commissioning, Sequence of Operation testing, and integrated system testing.

  Risk & Gap Identification: Proactively identify functional gaps, overlooked operational elements, safety risks, or unintended procedural consequences in the proposed DeltaV design, collaborating with DMO, DMMD, CDS, CQV, Quality, Engineering, and vendor partners to resolve them.

• 4. Operational & Safety Philosophy Input

  Access & Intervention: Provide operator-centric input on operator access philosophy, manual intervention requirements, and abnormal situation handling.

  Alarm & Interlock Management: Inform alarm response requirements, interlock philosophy, and equipment module operating parameters to ensure a safe, high-performing operating window.

  Safety Reviews: Participate actively in Process Hazard Analyses (PHA), Layers of Protection Analyses (LOPA), CHAZOPs, design safety reviews, 3D model reviews and final system handovers.

Key Performance Indicators (KPIs)

• Accuracy of Requirements: Minimal gaps or functional changes required during late-stage testing (FAT/SAT/Commissioning) due to complete operational translation during sprint cycles.

• Sprint Velocity Support: Timely turnaround of document reviews, clarifications, and user feedback within sprint boundaries to maintain the development schedule.

• Transition Readiness: Successful preparation of operating procedures and training inputs to ensure operators are ready to transition to DeltaV controls smoothly enabling RFT facility start-up.

Qualifications & Experience

Required:

• Operational Expertise: Significant hands‑on experience in biopharmaceutical drug substance and SDI operations, with a deep understanding of process equipment, utility systems, and facility layouts.

• Legacy System Knowledge: Strong familiarity with legacy API/SDI control system functionality and the ability to interpret existing operating sequences.

• Recipe Management Experience: Prior experience in recipe creation, batch sheet/EBR execution, and operational sequence design under computerized control environments.

• Commercial supply Experience: Hands‑on experience navigating the commercial supply phase of biopharmaceutical manufacturing, ensuring compliance with GMP and regulatory standards.

• Communication & Collaboration: Excellent communication skills with a proven track record of effectively translating complex operational procedures to engineering/automation teams and vice versa.

Preferred:

• DeltaV Experience: Familiarity with Emerson DeltaV system navigation, batch execution, or previous exposure to DeltaV system migration projects.

• Agile Exposure: Prior experience working in an Agile development environment (Scrum/Kanban), participating in sprint-based delivery.

• CQV Experience: Active participation in Commissioning, Qualification, and Validation (CQV) activities in a regulated pharmaceutical facility.