Senior Operations Specialist

Pacer Group; Elkton (VA); On-site; USD 52,000 - 55,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Pacer Group seeks an experienced Operations Specialist III (Senior) to serve as a SME within an Agile automation development team supporting DeltaV development, testing, and commissioning.

The role translates legacy DCS functionality into DeltaV automation requirements, converts batch sheets and EBRs into DeltaV elements, and supports FAT, DSAT, and commissioning activities in a regulated biopharmaceutical setting.

Qualifications

• Hands-on experience in biopharmaceutical drug substance/API manufacturing operations.
• Knowledge of legacy DCS systems, manufacturing processes, and operating sequences.
• Experience with batch recipes, batch sheets, and electronic batch records (EBRs).
• Strong understanding of GMP requirements and commercial pharmaceutical manufacturing.
• Ability to translate manufacturing workflows into automation requirements and collaborate with technical teams.

Responsibilities

• Translate legacy DCS functionality and manufacturing practices into DeltaV automation requirements.
• Convert batch sheets, recipes, and EBR workflows into DeltaV phases, recipes, control modules, and sequences.
• Review functional specifications, system requirements, design documents, test scripts, and SOPs.
• Support FAT, DSAT, commissioning, sequence-of-operation testing, and integrated testing activities.
• Identify process gaps, operational risks, and safety concerns; provide input on alarms, interlocks, and abnormal operating conditions.
• Participate in process hazard and design safety reviews, including PHA/LOPA/CHAZOP activities, and support manufacturing handover.

Skills

Biopharma ops

Legacy DCS

Batch records

GMP compliance

Automation requirements

Tools

DeltaV

Job description

Domain: Pharmaceutical Manufacturing / Biopharmaceuticals

Pay Rate: $38-$40/hr

Application Deadline: 20th Oct 2026

SKILLS REQUIRED

Primary (Must-Have)

• Hands-on experience in biopharmaceutical drug substance/API manufacturing operations
• Knowledge of legacy DCS systems, manufacturing processes, and operating sequences
• Experience with batch recipes, batch sheets, and electronic batch records (EBRs)
• Strong understanding of GMP requirements and commercial pharmaceutical manufacturing
• Ability to translate manufacturing workflows into automation requirements and collaborate with technical teams

Secondary (Good to Have):

• Experience with Emerson DeltaV automation systems
• Familiarity with Agile, Scrum, or Kanban methodologies
• Experience with Commissioning, Qualification, and Validation (CQV) in regulated pharmaceutical environments
• Experience with Factory Acceptance Testing (FAT), commissioning, and integrated system testing

POSITION OVERVIEW

We are seeking an experienced Operations Specialist III (Senior) to serve as a subject matter expert within an Agile automation development team supporting DeltaV development, testing, and commissioning.

ROLES & RESPONSIBILITIES

• Translate legacy DCS functionality and manufacturing practices into DeltaV automation requirements
• Convert batch sheets, recipes, and EBR workflows into DeltaV phases, recipes, control modules, and sequences
• Review functional specifications, system requirements, design documents, test scripts, and SOPs
• Support FAT, DSAT, commissioning, sequence-of-operation testing, and integrated testing activities
• Identify process gaps, operational risks, and safety concerns; provide input on alarms, interlocks, and abnormal operating conditions
• Participate in process hazard and design safety reviews, including PHA/LOPA/CHAZOP activities, and support manufacturing handover

BENEFITS

Medical | Dental | Vision | 401(k)

EEOC Compliance:

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.