About Us: WuXi Biologics is a world-class biologics services provider from discovery through to commercialization with global clients in the biopharmaceutical and healthcare industries.
We accelerate and transform discovery development and manufacturing in the fast-growing field of biologics to benefit patients worldwide. We have sites/offices in China US EU Asia and Israel with over 5,000 employees worldwide providing services to over 200+ clients globally including 13 of the top 20 biopharmaceutical companies.
The Delta V Lead
We are seeking an experienced Delta V Lead for a permanent contract opportunity. As a Delta V Lead you will be responsible for the site DeltaV systems supporting complex and challenging initiatives developing automation strategies planning and executing system roadmaps and deploying new technology in alignment with Corporate platform leads.
You will work closely with multiple disciplines including manufacturing process engineering process development utility operations maintenance quality assurance and validation to implement operational improvements.
Your Responsibilities:
1. Provide system administration and ownership support for Delta V and Utility systems. Support includes infrastructure and networking architecture user access patching security and compliance optimal performance for Delta V control system software/hardware reliability and end-user interface.
2. Provide technical support to commercial and clinical manufacturing as needed specific to process control and automation infrastructure.
3. Lead technical root cause analysis incident investigations and troubleshooting issues related to electrical instrumentation and equipment control systems.
4. Develop organize analyze and present results for operational issues and projects of moderate scope and complexity.
5. Lead and support system improvements development of detailed specification engineering documents and standard operating procedures.
6. SUPPORT NEW PRODUCT INTRODUCTIONS BY PERFORMING ENGINEERING ASSESSMENTS IMPLEMENTING AUTOMATION SYSTEM CONFIGURATION CHANGES AND SUPPORTING ENGINEERING RUNS.
7. Communicate proactively with supervisor and support staff highlighting issues and proposing solutions.
8. Manage and maintain software system licenses and support/maintenance contract renewals apply software updates patches and hot-fixes as required to keep automation engineering computer systems running efficiently with minimal downtime.
9. System owner responsibilities such as change control maintenance backup/restore and disaster recovery and regulatory compliance.
10. SUPPORT A SAFE WORKING ENVIRONMENT BY COMPLYING WITH ALL PERTINENT ENVIRONMENTAL HEALTH/SAFETY PRACTICE RULES AND REGULATIONS.
11. Perform all duties in accordance with GMP requirements SOPs and controlled documents.
12. FLEXIBILITY TO TAKE ON ADDITIONAL TASKS AND RESPONSIBILITIES AT THE DISCRETION OF THE AIS ASSOCIATE DIRECTOR.
13. Will act as a role model for the Engineering function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Your Profile:
The ideal candidate for this position will have the following qualifications:
* Bachelor’s degree in Electrical Engineering Computer Science Chemical Engineering Biotech Engineering or related life science engineering.
* Knowledge/experience: Required - Ability to create update and read P&IDs instrumentation and electrical design packages including SDS URS IQ OQ and VSR among other engineering and validation documentation. Minimum of 8 years experience in automation engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
* Direct hands-on experience with lifecycle management of DeltaV software hardware and infrastructure with extensive understanding and background in design programming and installation.
* Experience in Drug Substance Operations with Mammalian Cell Culture Protein Purification Media and Buffer Preparation Clean Utilities CIP SIP and Production Services.
* Direct experience in process control engineering and troubleshooting with bioreactors centrifuges chromatography columns and systems and/or ultrafiltration/diafiltration systems.
* Strong process control systems automation background.
* Strong network architecture or engineering proficiencies including TCP/IP Routing Switching Network IDS/IPS Active Directory Domain Integration and Firewalls.
* Experience with Tech Transfer Process Design and Commissioning.
* Experience with validation and change control methodology Experienced in change control non-conformance corrective and preventative actions and validation practices.
* Familiarity with industry standards for batch control systems software development life cycle methodologies 21 CFR Part 11 and GAMP.
* In-depth knowledge in programming language e.g. VBA.
* Familiarity with OSI PI Historian.
* Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context.
* Preferred - Knowledge of ASTM 2500 ISA S88 and S95 techniques.