Validation Engineer (Pharmaceutical Manufacturing)

skellig

About The Position

Specialist providers of pharmaceutical automation, process and project controls. Skellig was founded to radically improve upon the way automation, process, and project controls are provided. It’s a goal that is grounded in efficiency, transparency, and our client’s total peace of mind — this is the vision behind everything we do. At Skellig Automation, we empower great people to do great work in the Life Sciences industry. Our engineers provide premier automation services with one common goal: to make medicine more affordable and accessible for all by reducing the cost of manufacturing. We work alongside other industry leaders in laying the foundation for true technological innovation and guiding our partners towards modern process solutions. Whether working within the traditional automation stack or championing Industry 4.0 systems, Skellig has a place for creative engineers with a passion for bringing the Life Sciences into the future. Summary: We are seeking an experienced DeltaV Validation Engineer to join our team and support our clients. The ideal candidate will be responsible for ensuring the proper validation of DeltaV control systems in industrial automation settings, specifically within pharmaceutical, biotech, or chemical manufacturing environments. This role involves system testing, troubleshooting, documentation, and compliance with industry standards. To be considered for this role you must have experience working in biotech/pharma.

Requirements

5+ years’ direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations
3+ years’ direct Computer System Validation experience working with Emerson DeltaV DCS
Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
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 and efficiently in a team-based environment with employees at all levels
Ability to manage commitments while displaying an eagerness to learn and continuously improve

Nice To Haves

Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
MasterControl, ComplianceWire, TrackWise, and Veeva experience is a plus

Responsibilities

Review and approve Kneat documents including: DeltaV 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, reasonable 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 the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives
Coordinate with various project workstreams including Automation, Automation System vendor(s), 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.

Benefits

Vacation / Personal Paid Time Off
Sick Paid Time Off
Unlimited Unpaid Time Off
Paid Public Holidays
Parental Leave
Full Heath, Dental, and Vision PPO Insurance for you and any dependents - Premiums are 100% fully covered
Life Insurance and Accidental Death and Dismemberment
401k + Match
Relocation Package
…. And more!