Applications Automation Engineer
105 Digital Drive Novato, CA 94949
Bayside Solutions is seeking a Applications Automation Engineer I to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Applications Automation Engineer
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Support the existing PI Historian infrastructure utilized for manufacturing along with supporting the design, engineering, and commissioning of data collection for new manufacturing equipment.
- Support manufacturing, utilities, and laboratory users by assessing their needs for the PI Historian, and execute independent projects to meet those needs.
- Create a line of communication with vendors to troubleshoot and problems solve issues within the PI Historian environment.
- Investigate and diagnose technical issues and provide recommendations/solutions for corrective and preventative actions.
- Contribute to batch reporting projects/assignments in the support of site operations through requirements gathering, design support, report technical implementation, and test execution. Proactively look for and recommend improvements in site processes and procedures.
- Develop and deploy analytics to aid in batch context generation and production lot review.
- Create, edit, and review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Configuration Specifications, IQ/OQ).
- Manage requirements and run test scripts for system IQ/OQ in HP Quality Center.
- Support and/or execute acceptance testing and IOQ protocols.
- Follow established Quality Control systems and interface with the QA Validation group for GMP systems.
Summary of Qualifications:
- 0-3 years of experience in PI Historian, or other database use.
- Experience with PI Asset Framework a plus.
- 0-3 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
- 0-3 years of experience with the installation, startup, and servicing of process control systems.
- Experience with PLC and data acquisition systems, and process control systems a plus.
- Experience with developing GAMP documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans).
- Experience with networks and communication protocols (e.g. OPC DA, OPC AE, MODBUS etc.) preferred.
- Virtual Machines experience preferred.
- Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly preferred.
- Proficiency with standard Office software applications, including MS Word, MS Excel, MS Power Point, and MS Visio.
- Familiarity with HP Quality Center and/or Trackwise a plus.
- Strong organization, interpersonal, oral and written communication skills.
- Ability to self-direct and work both independently and in conjunction with cross-functional teams.
- BS or MS Chemical, Electrical, Mechanical Engineering, BioMedical Engineering or Computer Science from an accredited university.