Robotic Process Automation Engineer - Hyderabad, India - PSC Biotech Ltd
Description
AboutPSC Biotech
Who weare
PSC Biotech is a leading Biotech Consultancy firmfounded in 1996 headquartered in Pomona California USA with Globaloperations in Ireland India Singapore Australia and the US serving350 clients in more than 23 countries worldwide. We providecloudbased software solutions for Quality Management and RegulatoryInspections pharmaceuticals contract manufacturing professionalsand metrology services to ourclients.
Take yourCareer to a new Level
PSC Biotech disrupts theconventional consultancy model by aligning our EVP as one of theunique selling points which includes the opportunity to work withthe most talented cohort of likeminded professionals operating inthe Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical clientsites in a diversecultural worksetting.
EmployeeValue Proposition
Employees are the heartbeat of PSCBiotech we provide unparalleled empowering career developmentthough Learning & Development inhouse training mentorshipthrough constant guidance to facilitate career progression. Webelieve in creating high performing teams that can exceed ourclient s expectations with regards to quality of all scalable andbusiness unit deliverables staying under budget and ensuringtimelines for our deliverables are beingmet.
JobSummary:
Looking forcandidates who is having primary experience in UiPath processautomation.
This position isresponsible for equipment facilities and utilities automationqualification activities in a cGMP environment.
Thecandidate should have a strong background in Automation Validation.
This positionwill coordinate validate and manage projects related to equipmentimplementation and manufacturing process changes.
Theposition will primarily focus on the validation needs of newimplementations and changes but will assist the users withequipment design documentation review and approval of UserRequirement Specifications (URS) Functional RequirementSpecifications (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 agencyassessments/reports.
This positionwill be responsible for QA review of automation qualificationdocumentation serving clinical and commercial manufacturingfacilities.
Followingvalidation the position will assist with Regulatory documentassessment and drafting and with defending the work to regulatoryagencies.
Theposition organizes and performs qualification activities withminimalsupervision.
Requirements
RESPONSIBILITIES
Provide automationactivities project management oversight for new equipmentimplementations and process changes.
Coordinate withusers to map out requirements andspecifications.
Coordinate withEngineering to ensure that validation activities are appropriatelyplanned to coincide with the overall projectimplementation.
Review andapprove automation validation documentation for qualification ofequipment (supporting new process changes or large novel equipmentimplementations) including bioreactors autoclaves chromatographyequipment pressure vessels filling equipment etc. as well asfacilities and utility automation qualificationpackages.
Review andapproval of URS FRS SDD CS FAT SAT and AT documentation.
Assist withpreparation of regulatory filings with answering questions fromregulatory agencies and with presentation of materials inregulatoryinspections.
CreateSOPs/Guideline documents for implementation of automationqualification for both new and existing processchanges.
Maintain currentknowledge of industry standards and regulatory requirements forproducts developed or manufactured and validation approaches andsystemsutilized
RepresentValidation in multidepartmental meetings & projectteams.
Other duties asassigned.
Requirements
EDUCATION
BS/MS in atechnical discipline (physical engineering or biological sciencespreferred but not required).
Training inproject managementpreferred.
EXPERIENCE
3years experience in a cGMP regulated environment with exhibitedknowledge or proficiency in validation and changecontrol.
Organizationaland management skills to coordinate multidiscipline projectgroups
Ability to speakpresent data and defend approaches in front of audiences andinspectors.
Ability tocomprehend technical information related to equipment processes andregulatoryexpectations.
Experience withparticipation in regulatory inspections with experience inpresenting or defending departmental functions in audits andregulatoryinspections.
Proficiency withstandard office software applications including MS Word MS Excel MSProject MS Power Point. Experience and proficiency with otherapplications (such as Power BI aplus).
Understandingand familiarity with FDA & European regulatory requirementsguidelines and recommendations for validation expectations.(Understanding of regulatory guidelines for other countries aplus).
#LIKV1
RESPONSIBILITIES Provide automation activities project managementoversight for new equipment implementations and process changes.Coordinate with users to map out requirements and specifications.Coordinate with Engineering to ensure that validation activitiesare appropriately planned to coincide with the overall projectimplementation. Review and approve automation validationdocumentation for qualification of equipment (supporting newprocess changes or large novel equipment implementations) includingbioreactors, autoclaves, chromatography equipment, pressurevessels, filling equipment, etc. as well as facilities and utilityautomation qualification packages. Review and approval of URS, FRS,SDD, CS, FAT, SAT and AT documentation. Assist with preparation ofregulatory filings, with answering questions from regulatoryagencies, and with presentation of materials in regulatoryinspections. Create SOPs/Guideline documents for implementation ofautomation qualification for both new and existing process changes.Maintain current knowledge of industry standards and regulatoryrequirements for products developed or manufactured by BioMarin andvalidation approaches and systems utilized Represent Validation inmulti-departmental meetings & project teams. Other duties asassigned. Requirements EDUCATION BS/MS in a technical discipline(physical, engineering or biological sciences preferred but notrequired). Training in project management preferred. EXPERIENCE 3+years' experience in a cGMP regulated environment, with exhibitedknowledge or proficiency in validation and change control.Organizational and management skills to coordinate multi-disciplineproject groups Ability to speak, present data, and defendapproaches in front of audiences and inspectors. Ability tocomprehend technical information related to equipment, processes,and regulatory expectations. Experience with participation inregulatory inspections, with experience in presenting or defendingdepartmental functions in audits and regulatory inspections.Proficiency with standard office software applications, includingMS Word, MS Excel, MS Project, MS Power Point. Experience andproficiency with other applications (such as Power BI a plus).Understanding and familiarity with FDA & European regulatoryrequirements, guidelines, and recommendations for validationexpectations. (Understanding of regulatory guidelines for othercountries a plus). #LI-KV1