##### Job Description :
The site and position focus is primarily on safety and quality, followed by
the efficient delivery of medicines in alignment with regulatory requirements,
the site production plan and corporate / network priorities. The successful
candidate must have a passion for applying computer system technologies to
deliver life-changing medicines to patients while improving the speed and
consistency of the delivery of business results.
##### **Responsibilities:**
* Author and maintain computer system design documentation and engineering diagrams
* Implement new systems, incremental changes and upgrades to meet user requirements and ensure continuity of vendor support
* Assess the impact of proposed changes from other groups / departments
* Apply computer system validation and change control per site and department procedures
* Perform periodic reviews and revalidations per quality standards and validation protocols
* Troubleshoot system alerts and failures, including remediation of emergent issues outside of standard business hours (on call rotation)
* Perform Quality discrepancy evaluations/assessments and provide support for investigations
* Collaborate with Manufacturing, Quality, F&E (Facilities and Engineering), MSAT (Manufacturing Science and Technology) departments and global IT to implement corrective actions and changes related to expense/capital projects
* Provide system virtualization administration, user administration, security, monitoring, data integrity, inspection support, training, backup and recovery services
* Mentor and train new engineers and contractors
* On site presence is required
##### **Requirements/Qualifications:**
* BS or MS degree in Computer Science, Engineering or equivalent education and experience
* Minimum of 2-4 years of relevant experience, preferably in the biopharmaceutical, pharmaceutical, food and beverage, or other regulated batch processing industries
* Understanding of basic engineering techniques and principles as applied to projects
* Experience with automated systems lifecycle support
* Understanding of cGMP (current Good Manufacturing Practice) concepts, particularly as they relate to the operation, validation and maintenance of computer-controlled systems
* Excellent organization and communication skills
* Ability to work independently or as part of a multidisciplinary team
* Ability to acquire, through training and/or on the job experience, specialized knowledge in rapidly changing technology and applications
##### **Nice to Have:**
* Experience with HPE and/or Dell blade enclosures and blade servers
* Experience with VMware and/or Hyper-V server virtualization & hypervisors
* Experience with Microsoft Windows Server operating system, Microsoft SQL Server, and development tools
* Experience with computer hardware
* Experience with the cybersecurity of control systems, operating systems, and applications
* Experience with active directory and group policy configuration
* Experience with networking (LAN/WAN) including TCP/IP (Transmission Control Protocol/Internet Protocol)
* Experience with anti-virus software, intrusion detection, and firewalls
* Experience with Siemens/Moore Products APACS, AVEVA/Wonderware ArchestrA/InBatch, Honeywell Experion and TotalPlant Batch, POMS Corporation POMSnet, MatrikonOPC, OSIsoft PI and/or Rockwell Automation applications
* Experience with scripting and programming (Visual Basic, Java, Net, C++, Python, Bash, PowerShell) strongly preferred
##### **Benefits:**
Genentech is an equal opportunity employer, and we embrace the increasingly
diverse world around us. Genentech prohibits unlawful discrimination based on
race, color, religion, gender, sexual orientation, gender identity or
expression, national origin or ancestry, age, disability, marital status and
veteran status.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of
their start date. This requirement is a condition of employment at Genentech,
and it applies regardless of whether the position is located at a Genentech
campus or is fully remote. If you are unable to receive the vaccine due to a
disability or serious medical condition, or because it is prohibited as a
result of your sincerely held religious beliefs, you will have an opportunity
to request a reasonable accommodation.
