Warehouse Project Automation Lead

🔥 2 hours ago

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Pinnaql

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Pinnaql is a life‑sciences technical and compliance services firm. It partners with pharmaceutical, biotechnology, radiopharma, cell & gene therapy (CGT), medical device companies, CDMOs and compounding pharmacies to deliver quality systems, lab and manufacturing technical operations, validation (CQV/CSV), automation and digital transformation, and engineering/project management support. Core services include QMS development and eQMS, regulatory and audit support, SOP/CAPA/deviation management, computer system validation and 21 CFR Part 11 compliance, LIMS and data integrity support, equipment and analytical method validation, commissioning/qualification/validation, process and cleaning validation, and automation/robotics integration. Pinnaql's experts embed with client teams to improve compliance, accelerate timelines, optimize manufacturing readiness and support tech transfer from development to commercialization. Offices are listed in Malvern, PA and Indianapolis, IN.

📋 Description

• Technical ownership for Warehouse 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&ID and control strategy reviews • 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 etc.) • Communicate progress, issues, and needs to automation technical lead for the project • Provide input, review, and approve functional requirements and specifications • Develop and partner with the selected System Integrator to create computer system validation deliverables • Secure vendor documents for skidded equipment to integrate with validation deliverables • Responding to system integrator technical queries • Identification of any remediation effort required on process control software • Assist the System Integrator in the implementation of the system architecture. • 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

🎯 Requirements

• BS Engineering (or equivalent experience) • 8+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing) • Previous Pharmaceutical Automation Large Project/Program experience/expertise • 5+ years experience in Allen-Bradley PLCs • Previous experience in a Warehouse Building preferable • Exceptional teamwork abilities • Strong knowledge of GMPs, regulatory requirements and computer system validation principles • Excellent written and verbal communication skills for both technical and non-technical audiences.

🏖️ Benefits

• Health insurance • Professional development opportunities