Robotic Process Automation Engineer

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 cloudbased 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 likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Job Summary:

Looking for candidates who is having 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 position will primarily focus on the validation needs of new implementations and changes but will assist the users with equipment design documentation review and approval of User Requirement Specifications (URS) Functional Requirement Specifications (FRS) Software Design Descriptions (SDD) Configuration Specifications (CS) Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) ) Automation Test Script (ATs) establishing acceptance criteria and support regulatory agency assessments/reports.

This position will be responsible for QA review of automation qualification documentation serving clinical and commercial manufacturing facilities.

Following validation the position will assist with Regulatory document assessment and drafting and with defending the work to regulatory agencies.

The position organizes and performs qualification activities with minimal supervision.

Requirements

RESPONSIBILITIES

Provide automation activities project management oversight for new equipment implementations and process changes.

Coordinate with users to map out requirements and specifications.

Coordinate with Engineering to ensure that validation activities are appropriately planned to coincide with the overall project implementation.

Review and approve automation validation documentation for qualification of equipment (supporting new process changes or large novel equipment implementations) including bioreactors autoclaves chromatography equipment pressure vessels filling equipment etc. as well as facilities and utility automation qualification packages.

Review and approval of URS FRS SDD CS FAT SAT and AT documentation.

Assist with preparation of regulatory filings with answering questions from regulatory agencies and with presentation of materials in regulatory inspections.

Create SOPs/Guideline documents for implementation of automation qualification for both new and existing process changes.

Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured and validation approaches and systems utilized

Represent Validation in multidepartmental meetings & project teams.

Other duties as assigned.

Requirements

EDUCATION

BS/MS in a technical discipline (physical engineering or biological sciences preferred but not required).

Training in project management preferred.

EXPERIENCE

3 years experience in a cGMP regulated environment with exhibited knowledge or proficiency in validation and change control.

Organizational and management skills to coordinate multidiscipline project groups

Ability to speak present data and defend approaches in front of audiences and inspectors.

Ability to comprehend technical information related to equipment processes and regulatory expectations.

Experience with participation in regulatory inspections with experience in presenting or defending departmental functions in audits and regulatory inspections.

Proficiency with standard office software applications including MS Word MS Excel MS Project MS Power Point. Experience and proficiency with other applications (such as Power BI a plus).

Understanding and familiarity with FDA & European regulatory requirements guidelines and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus).