Robotic Process Automation Support Engineer

PSC Biotech Corporation; California (MO); Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Robotic Process Automation Support Engineer to join their dynamic team. This remote role focuses on supporting automation qualification activities in a cGMP environment. You will manage projects related to equipment implementation and process changes, ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in UiPath process automation and a strong background in validation. Join a forward-thinking company that values career development, offers mentorship, and fosters a diverse work culture. This is an opportunity to make a significant impact in the Pharma/Biotech sector while working with talented professionals globally.

Qualifications

• 5+ years in a cGMP regulated environment with knowledge of validation.
• Strong organizational and management skills for coordinating projects.

Responsibilities

• Provide project management oversight for automation activities.
• Ensure validation activities are aligned with project timelines.
• Review and approve automation validation documentation.

Skills

UiPath process automation

Automation Validation

Project Management

Regulatory Compliance

Communication Skills

Technical Documentation

Education

BS/MS in a technical discipline

Project management training

Tools

MS Word

MS Excel

MS Project

MS PowerPoint

Power BI

Job description

Robotic Process Automation Support Engineer

• Industry: Pharma/Biotech/Clinical Research
• Work Experience: 5+ years
• Remote Job

Job Description

This is a remote position.

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your career to a new level’
PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, including the opportunity to work with talented professionals in the Pharma/Biotech industry. We provide permanent contracts, exposure to top pharmaceutical client sites, and a diverse cultural work environment.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We offer empowering career development through learning, in-house training, mentorship, and guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations regarding quality, budget, and timelines.

Job Summary:

This role is focused 100% on support activities.

We are looking for candidates with primary experience in UiPath process automation.

· Responsible for equipment, facilities, and utilities automation qualification activities in a cGMP environment.
· Strong background in Automation Validation required.
· Coordinate, validate, and manage projects related to equipment implementation and process changes.
· Focus on validation of new implementations and changes; assist users with documentation review and approval (URS, FRS, SDD, CS, FAT, SAT, ATs), establish acceptance criteria, and support regulatory assessments.
· QA review of automation qualification documentation for clinical and commercial manufacturing facilities.
· Assist with regulatory document assessment, drafting, and defense.
· Organize and perform qualification activities with minimal supervision.

Requirements

Responsibilities

• Provide project management oversight for automation activities related to new equipment and process changes.
• Coordinate with users to gather requirements and specifications.
• Ensure validation activities are aligned with project timelines.
• Review and approve automation validation documentation for equipment qualification, including bioreactors, autoclaves, chromatography equipment, etc., as well as facilities and utility automation packages.
• Review and approve URS, FRS, SDD, CS, FAT, SAT, and AT documentation.
• Assist in preparing regulatory filings and responding to regulatory agency questions.
• Create SOPs and guidelines for automation qualification processes.
• Stay updated on industry standards and regulatory requirements.
• Represent validation in cross-departmental meetings and project teams.
• Perform other duties as assigned.

Requirements

Education

• BS/MS in a technical discipline (physical, engineering, or biological sciences preferred but not required).
• Project management training preferred.

Experience

• 5+ years in a cGMP regulated environment with knowledge of validation and change control.
• Strong organizational and management skills for coordinating multi-disciplinary projects.
• Excellent communication skills for presenting data and defending approaches.
• Technical understanding of equipment, processes, and regulatory expectations.
• Experience participating in regulatory inspections and audits.
• Proficiency in MS Word, Excel, Project, PowerPoint, and other applications like Power BI.
• Knowledge of FDA and European validation and regulatory guidelines; familiarity with other countries' regulations is a plus.