Automation Workstream Manager

Job Title : Automation Workstream Manager

Location : REMOTE INITIALLY , with on-site visits in Texas or Virginia during key phases

Experience Required : 10+ Years

Contract Duration : 24+ months

About the Role

We are seeking an experienced Automation Workstream Manager to lead automation activities for the small molecule drug product manufacturing workstream on a large-scale greenfield pharmaceutical project. The role will focus on designing, integrating, and commissioning automated manufacturing lines, ensuring systems are delivered on time, within budget, and in compliance with regulatory and operational standards.

Key Responsibilities

Lead the small molecule manufacturing workstream, managing scope, schedule, and budget for automation activities.

Oversee development and approval of automation deliverables (URS, FRS, DS, FAT / SAT protocols) using electronic documentation systems.

Coordinate with engineering, construction, validation, and vendor teams to ensure seamless integration of automation systems.

Drive commissioning, qualification, and validation activities for automation systems.

Ensure compliance with GMP, regulatory requirements, and cybersecurity standards.

Provide leadership and support during audits and inspections related to automation systems.

Qualifications

Bachelor's degree in Engineering (Automation, Chemical, or related field); advanced degree preferred.

10+ years of experience in automation project management for pharmaceutical or biotech facilities.

Strong knowledge of DeltaV DCS, Rockwell PLC, and integration with MES and BMS systems.

Experience with electronic documentation systems (e.g., Kneat).

Proven ability to manage large-scale capital projects with aggressive timelines.

Familiarity with C&Q processes and regulatory compliance (FDA, EMA).

Excellent leadership, problem-solving, and communication skills.

Additional Details

Initial remote work for approximately 6 12 months during construction phase.

On-site presence in Texas or Virginia may be required for project milestones.

Highly vetted candidates with references will be preferred.