Apollo Professional Solutions
Computer System CSV Support
Apollo Professional Solutions, Hillsboro, Oregon, United States, 97104
Job Description
Job DescriptionOnsite in Hillsboro, ORMission:This position, based in Hillsboro, Oregon, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the local IT OT organization, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Aseptic filling for Drug Product and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.What you'll be working on:Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks and validation activities.This includes activities like:
Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testingUpdate System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT)Help perform MILE (system maintenance) activities for ITOT SystemsPerform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year's worth of planned and unplanned events, review impact on system's validated state and draft reports.Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT SystemsSupport System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.Support validation activities, generation, approval and execution of validation protocolsAssist System Owners in the Periodic System Audit Trail ReviewUser account auditing, provisioning, resets and activation for all IT and OT systemsCreating reports for various systems on demandWork with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.Review ServiceNow tickets and either address them or route them to the SMESupport on documents management systems (Veeva, Condor, eVal Roche)Support the team with administrative tasksRole Minimum RequirementsEducationMinimum Bachelor's degree in Computer Engineering, Automation Engineering or similarMinimum 5 years of experience in system and/or network administrationCompetencies
Management skillsAttention to details and good problem-solving skillsDemonstrated ability to think and solve problems at a system-levelAbility to work and interact productively with stakeholders from different technical domainsAbility to multi-task with a calm behavior and work under pressure in a fast-paced environmentGood team player, self-confident, motivated, and independentGood communication skillsTechnical skills
System AdministrationNetwork AdministrationExperience with industrial data and control interfaces, preferably OPC and OPC-UASystem administration, supporting multiple platforms and applicationsAbility create and execute validation on computerized systemsBiopharmaceutical or similar Manufacturing domain knowledge.Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, SmartManufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity,Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21CFR Part 11,cGMP Annex 11, Data Integrity principles.Entrepreneurial mindset e.g. "automating automation"
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
Meet Your Recruiter
Nikhil Patel
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Job DescriptionOnsite in Hillsboro, ORMission:This position, based in Hillsboro, Oregon, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the local IT OT organization, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Aseptic filling for Drug Product and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.What you'll be working on:Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks and validation activities.This includes activities like:
Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testingUpdate System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT)Help perform MILE (system maintenance) activities for ITOT SystemsPerform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year's worth of planned and unplanned events, review impact on system's validated state and draft reports.Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT SystemsSupport System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.Support validation activities, generation, approval and execution of validation protocolsAssist System Owners in the Periodic System Audit Trail ReviewUser account auditing, provisioning, resets and activation for all IT and OT systemsCreating reports for various systems on demandWork with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.Review ServiceNow tickets and either address them or route them to the SMESupport on documents management systems (Veeva, Condor, eVal Roche)Support the team with administrative tasksRole Minimum RequirementsEducationMinimum Bachelor's degree in Computer Engineering, Automation Engineering or similarMinimum 5 years of experience in system and/or network administrationCompetencies
Management skillsAttention to details and good problem-solving skillsDemonstrated ability to think and solve problems at a system-levelAbility to work and interact productively with stakeholders from different technical domainsAbility to multi-task with a calm behavior and work under pressure in a fast-paced environmentGood team player, self-confident, motivated, and independentGood communication skillsTechnical skills
System AdministrationNetwork AdministrationExperience with industrial data and control interfaces, preferably OPC and OPC-UASystem administration, supporting multiple platforms and applicationsAbility create and execute validation on computerized systemsBiopharmaceutical or similar Manufacturing domain knowledge.Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, SmartManufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity,Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21CFR Part 11,cGMP Annex 11, Data Integrity principles.Entrepreneurial mindset e.g. "automating automation"
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
Meet Your Recruiter
Nikhil Patel
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