Overview The
API Manufacturing Operations Subject Matter Expert (SME) position is an exciting opportunity to join PM Group's quickly growing US Outsourced Technical Services (OTS) team located out of any of the
Greater Richmond, VA area. Outsourced Technical Services (OTS) is an integral part of PM Group's ability to support clients across the complete project life cycle. We have over 50 years' industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group's ongoing expansion in the US.
The API Manufacturing Operations Subject Matter Expert (SME) will support a major pharmaceutical manufacturing project in the Greater Richmond, VA area. The SME will serve as the Operations representative within a cross-functional team developing and implementing an Emerson DeltaV control system. This individual will ensure 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 ideal candidate brings extensive hands-on API/drug substance manufacturing experience, commercial GMP knowledge, and familiarity with process automation and distributed control systems (DCS).
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, ensuring the system supports safe, efficient, and compliant manufacturing operations.
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 existing manufacturing procedures, DCS functionality, operating sequences, and shop-floor knowledge into clear 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 directly with automation engineers to ensure software reflects how equipment and manufacturing processes need to operate 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 potential operational gaps, process risks, safety issues, or unintended consequences before they surface during commissioning or startup.
- Provide input into alarm management, interlocks, operator access, manual intervention, abnormal situation handling, and control-system graphics.
- Collaborate closely 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.
Qualifications - 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 with the ability to explain complex manufacturing processes and operational requirements to automation engineers and other technical stakeholders.
Preferred Qualifications:
- 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.
Pay Range Disclosure: The pay range for this position is $150,000 - $175,000 annually. This range represents the base salary that PM Group reasonably expects to pay for this role at the time of posting. The actual compensation offered will depend on factors such as work location, qualifications, skills, and relevant experience.
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