API Manufacturing Operations SME

PM Group•Richmond, VA

About The Position

The API Manufacturing Operations Subject Matter Expert (SME) will support a major pharmaceutical manufacturing project in the Greater Richmond, Virginia area as the Operations representative within a cross-functional team developing and implementing an Emerson DeltaV control system. The SME ensures that manufacturing processes, equipment functionality, batch recipes, and operating sequences are accurately reflected in the automated control system throughout development, testing, commissioning, and startup. The role calls for hands-on API or drug substance manufacturing experience, commercial GMP knowledge, and familiarity with process automation and distributed control systems. This is not a software programming position. The primary responsibility is to translate manufacturing operations knowledge into clear, actionable requirements for automation engineers and developers so the system supports safe, efficient, and compliant manufacturing operations. PM Group is an employee-owned international project delivery firm with more than 4,000 people and over 50 years of industry experience. Its Outsourced Technical Services team provides experienced technical professionals who complement client project teams across the project life cycle. PM Group works in the pharma, food, biotech, medical technology, and mission-critical sectors, and states that its business strategy centers on its people, clients, trade partners, and sustainability.

Requirements

Significant hands-on experience supporting small-molecule API, pharmaceutical drug substance, or comparable batch chemical manufacturing operations.
Strong understanding of pharmaceutical manufacturing equipment, process operations, utilities, operating sequences, and facility interfaces.
Experience working in a commercial GMP manufacturing environment.
Practical experience with batch processes, recipes, batch sheets, and/or electronic batch records.
Ability to understand existing DCS-controlled processes and translate operating requirements into actionable requirements for automation or controls teams.
Experience supporting manufacturing troubleshooting, process changes, startup, commissioning, or system implementation.
Demonstrated ability to work effectively between Manufacturing Operations and technical Engineering/Automation organizations.
Strong communication skills and ability to explain complex manufacturing processes and operational requirements to automation engineers and other technical stakeholders.

Nice To Haves

Experience with Emerson DeltaV, including system navigation, batch execution, recipe management, or DeltaV migration/implementation projects.
Experience supporting automation development, DCS migrations, control-system upgrades, or major capital projects.
Experience with FAT, SAT, commissioning, CQV, and manufacturing startup.
Familiarity with Agile/Sprint-based project delivery.
Experience reviewing functional specifications, control narratives, sequence-of-operation documents, or automation test scripts.
Experience participating in PHA, LOPA, CHAZOP, or other process safety activities.

Responsibilities

Serve as the Operations/Process SME within a cross-functional automation development team, providing practical input on manufacturing processes, equipment operation, recipes, operator workflows, and facility constraints.
Translate manufacturing procedures, DCS functionality, operating sequences, and shop-floor knowledge into requirements for DeltaV configuration, graphics, control modules, equipment modules, and automated sequences.
Interpret batch sheets, electronic batch records (EBRs), recipes, and operating procedures and help translate them into automated phases, recipes, and sequential operations.
Work with automation engineers to ensure software reflects equipment and manufacturing process needs under normal, abnormal, and manual-intervention scenarios.
Review Functional Design Specifications (FDS), Software Requirement Specifications (SRS), test scripts, operating procedures, and related technical documentation for operational accuracy.
Participate in design reviews, software demonstrations, Factory Acceptance Testing (FAT), system testing, commissioning, Sequence of Operation testing, and integrated system testing.
Identify operational gaps, process risks, safety issues, or unintended consequences before commissioning or startup.
Provide input on alarm management, interlocks, operator access, manual intervention, abnormal situation handling, and control-system graphics.
Collaborate with Operations, Automation, Engineering, Quality, CQV, and vendor teams throughout project execution and startup.
Participate in process safety and design reviews, including PHA, LOPA, CHAZOP, and related assessments as appropriate.