Project Automation Area Lead

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

This is a hybrid opportunity and can be based anywhere in the United States, but will require travel to Indiana a minimum of 1 week a month based on project needs.

The Automation Area Lead will be responsible for the control system solution for an area within a project ensuring the solution is aligned with the overall program automation philosophy, standards and user requirements. The area lead will work in conjunction with the other members of the Project Team, including the Automation Project Manager, Automation Technical Lead, Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.

• Technical ownership for an area in a project
• Define the S88 software structure and list for the area
• Develop draft function design specifications for the area
• Work with system integrators to finalize the functional specifications
• Participate in P& control strategy reviews
• Work closely with the Project Technical Lead and System Integrator to successfully deliver the project on schedule and budget
• Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
• Ensure consistency of the automation deliverables in the area (requirements, functional specifications, control strategies, phases, and recipes, etc.)
• Assist in defining the software components that need to be created or modified
• Communicate progress, issues, and needs to automation technical lead for the project
• Provide input, review, and approve functional requirements and specifications
• Develop Parameter and Recipe Specification documents
• Respond to system integrator technical queries
• Identification of any remediation effort required on process control software
• Create items in the issue tracker as issues arise after the software acceptance
• Identify and analyze risks of technical nature particular to the area and planning responses
• Maintain compliance with training requirements

• 8+ years working Automation experience in the Pharmaceutical industry
• Previous Pharmaceutical Automation Large Project/Program experience
• 5+ years’ experience in DeltaV Batch DCS
• Exceptional teamwork abilities
• Strong knowledge of GMP’s, regulatory requirements and computer system validation principles
• Excellent written and verbal communication skills for both technical and non-technical audiences

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.