Validation Engineer; Pharmaceutical Manufacturing

Overview

Validation Engineer (Pharmaceutical Manufacturing) — North Carolina

Specialist providers of pharmaceutical automation, process and project controls. Skellig Automation was founded to improve automation, process, and project controls with efficiency, transparency, and client peace of mind at the core.

At Skellig Automation, we empower great people to do great work in the Life Sciences industry. Our engineers provide premier automation services with the goal of making medicine more affordable and accessible by reducing manufacturing costs. We collaborate with industry leaders to enable modern process solutions and drive innovation.

Whether working within traditional automation or championing Industry 4.0, Skellig values creative engineers who help bring Life Sciences into the future.

• Review and approve Kneat documents including Delta
  
  V software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
• Assist in resolving protocol execution issues using critical analysis and develop sound solutions.
• Support generation of Kneat documents.
• Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, traceability matrices, release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as needed.
• Ensure that Computer System Validation is conducted to a high standard, within budget, and that objectives are met on time aligned with company objectives.
• Coordinate with project work streams including Automation, Automation System vendors, CSV, CQV, Utilities, Process Engineering, and others as needed.
• Attend regularly scheduled project status meetings as needed.
• Complete Safety, Project Procedure, and Project Instruction training as required.

• 5+ years’ direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
• 3+ years’ direct Computer System Validation experience with Emerson Delta
  
  V DCS
• Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM
  2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex
  11
• Working knowledge of Kneat validation software is required
• Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
• Excellent interpersonal skills and ability to work effectively in a team-based environment
• Ability to manage commitments while showing eagerness to learn and continuously improve
• Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
• Master Control, Compliance Wire, Track Wise, and Veeva experience is a plus

• Vacation / Personal Paid Time Off
• Sick Paid Time Off
• Unlimited Unpaid Time Off
• Paid Public Holidays
• Full Health, Dental, and Vision PPO Insurance for you and dependents — Premiums covered
• Life Insurance and Accidental Death and Dismemberment

From its inception, Skellig has strived to be ‘more human.’ We work hard to foster a culture that promotes innovation, diversity, and great work. A culture that rewards problem solving, teamwork, and service excellence, and that attracts top talent and premier clients. Our culture emphasizes honesty, transparency, and kindness—a people-focused and compassionate company.

Skellig is an equal opportunity employer. We do not discriminate on the basis of any protected status. We encourage candidates from all backgrounds to apply.