Robotic Process Automation Support Engineer

PSC Biotech; California (MO); Remote; USD 80,000 - 120,000; 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, ensuring compliance with regulatory standards. Candidates should have extensive experience in UiPath process automation and a strong background in automation validation. This position offers unparalleled career development opportunities, allowing you to work with top pharmaceutical clients and make a significant impact in the industry. If you are passionate about automation and regulatory compliance, this is the perfect opportunity for you.

Qualifications

• 5+ years in a cGMP regulated environment with validation knowledge.
• Strong background in Automation Validation and project management.

Responsibilities

• Coordinate and manage automation qualification activities.
• Review and approve automation validation documentation for equipment.

Skills

UiPath Process Automation

Automation Validation

Project Management

Regulatory Compliance

Organizational Skills

Communication Skills

Education

BS/MS in 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 aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment, providing exposure to top pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide unparalleled career development opportunities through in-house training, mentorship, and continuous guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations in quality, stay within budget, and meet project timelines.

Job Summary:

The role is focused 100% on support activities.

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

· This position is responsible for equipment, facilities, and utilities automation qualification activities in a cGMP environment.

· The candidate should have a strong background in Automation Validation.

· This position will coordinate, validate, and manage projects related to equipment implementation and manufacturing process changes.

· The role will focus on validation for new implementations and changes, and will assist users with equipment design documentation review, approval of URS, FRS, SDD, CS, FAT, SAT, ATs, establishing acceptance criteria, and supporting regulatory assessments/reports.

· Responsible for QA review of automation qualification documentation for clinical and commercial manufacturing facilities.

· Post-validation, assist with regulatory document assessment, drafting, and defending work to regulatory agencies.

· 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.

· Coordinate with Engineering to plan validation activities aligned with project implementation.

· Review and approve automation validation documentation for equipment qualification, including bioreactors, autoclaves, chromatography equipment, pressure vessels, filling equipment, etc., as well as facilities and utility automation qualification packages.

· Review and approve URS, FRS, SDD, CS, FAT, SAT, and AT documentation.

· Assist in preparing regulatory filings, respond to regulatory questions, and present materials during inspections.

· Create SOPs and guidelines for automation qualification implementation.

· Stay current with industry standards and regulatory requirements for validation processes and systems.

· Represent Validation in multi-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' experience in a cGMP regulated environment, with knowledge or proficiency in validation and change control.

· Organizational and management skills for coordinating multi-disciplinary projects.

· Ability to present data, defend approaches, and communicate effectively with audiences and inspectors.

· Technical understanding of equipment, processes, and regulatory expectations.

· Experience participating in regulatory inspections and defending departmental functions during audits.

· Proficiency with MS Word, Excel, Project, PowerPoint, and other applications like Power BI.

· Familiarity with FDA and European regulatory validation guidelines; knowledge of other countries' regulations is a plus.