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Computer System CSV Support
4625 NE Brookwood Pkwy Helvetia, OR 97124 US
Job Description
IT OT Computer System CSV Support
Job Description
Mission:
This position 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 Technical Operations 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 youll 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 include activities like:
- Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing Update 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 Systems
- Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 years worth of planned and unplanned events, review impact on systems 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 Systems
- Support 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 protocols Assist System Owners in the Periodic System Audit Trail Review User account auditing, provisioning, resets and activation for all IT and OT systems Creating reports for various systems on demand
- Work 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 SME Support on documents management systems (Veeva, Condor, eVal) Support the team with administrative tasks
Role Minimum Requirements
- Minimum Bachelors degree in Computer Engineering, Automation Engineering or similar
- Minimum 5 years of experience in system and/or network administration
Competencies
- Management skills Attention to details and good problem-solving skills Demonstrated ability to think and solve problems at a system-level Ability to work and interact productively with stakeholders from different technical domains Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment Good team player, self-confident, motivated, and independent Good communication skills
- Technical skills System Administration Network Administration Experience with industrial data and control interfaces, preferably OPC and OPC-UA System administration, supporting multiple platforms and applications Ability create and execute validation on computerized systems
- Biopharmaceutical 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, Smart Manufacturing, 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, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles. Entrepreneurial mindset e.g. "automating automation"
Pay Rate Range: $40-80/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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