Position: Automation Area Lead (Remote) - Life Sciences/Pharma Experience Needed
Travel Requirement: Remote role with occasional travel - approximately 4 days per month to the customer site.
Purpose of the Role
The Automation Area Lead will be responsible for delivering the control system solution for a designated area within a project, ensuring alignment with the overall program automation philosophy, standards, and user requirements. This role involves close collaboration with the Project Team, including the Automation Project Manager, Automation Technical Lead, other Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.
Key Responsibilities
- Take technical ownership for an assigned area within the project.
- Define the S88 software structure and list for the area.
- Develop draft functional design specifications for the area.
- Work with system integrators to finalize functional specifications.
- Participate in P&ID and control strategy reviews.
- Collaborate with the Project Technical Lead and System Integrator to deliver the project on schedule and within budget.
- Ensure the automation solution aligns with the overall program automation philosophy and standards.
- Maintain consistency of automation deliverables (requirements, functional specifications, control strategies, phases, recipes, etc.).
- Assist in defining software components that need to be created or modified.
- Communicate progress, issues, and needs to the automation technical lead.
- Provide input, review, and approve functional requirements and specifications.
- Develop Parameter and Recipe Specification documents.
- Respond to system integrator technical queries.
- Identify remediation efforts required on process control software.
- Track and manage issues post-software acceptance.
- Identify and analyze technical risks specific to the area and plan responses.
- Maintain compliance with training requirements.
Large-Scale Project Experience Requirement
For this role, we are specifically looking for someone with large-scale automation project experience.
This means:
- Ownership of full process areas or workstreams in multi-line or multi-unit facilities.
- Coordination across multiple disciplines (process, utilities, validation, IT/OT, etc.).
- Accountability for architecture, standards, and long-term maintainability - not just implementation tasks.
Smaller-scale experience (executing individual systems, skids, or packages within a larger program where architecture and standards are defined by others) is valuable, but this position requires operating at the area-ownership and architecture-governance level.
Role Requirements
- BS in Engineering (or equivalent experience).
- 8+ years of automation experience in the pharmaceutical industry (preferably in API/bulk manufacturing).
- Previous experience in large pharmaceutical automation projects/programs.
- 5+ years' experience with DeltaV Batch DCS.
- Preferable: experience with Allen-Bradley PLCs. * Strong teamwork and collaboration skills.
- In-depth knowledge of GMPs, regulatory requirements, and computer system validation principles.
- Excellent written and verbal communication skills for both technical and nontechnical audiences.