Sr. Automation Engineer
About Project Farma
Project Farma (PF) is a rapidly growing professional service company headquartered in Chicago, IL. We consult in the pharmaceutical, biotechnology, medical device, and gene and cell therapy industries providing cGMP and industry best practices to our clients. We are an industry leader in providing project management, validation, engineering, quality/compliance and consulting services to support finding ground-breaking treatments and solutions. Our clients include early stage startups, established life science companies and CMOs / CROs. Our family-oriented culture strives to develop and leverage your interpersonal skills and technical experience for long term success.
Purpose and Scope of Position
We are looking for a highly motivated Sr. Automation Engineer providing manufacturing support including working on processing equipment in clean and mechanical spaces within a manufacturing facility in the South San Francisco area. This individual will be responsible for providing support for bio-pharmaceutical manufacturing projects and operations for the Downstream Automation group with a focus on Drug Product. Area of focus will primarily be supporting manufacturing computer/automation/process control systems to ensure reliable operation of Drug Product systems, including Commercial and Clinical fill lines and associated control systems used in and supporting bulk processing, the filling of recombinant proteins, packaging, and inspection. Candidate must be a self-starter, who can independently drive projects and day to-day work tasks to completion according to a defined budget and schedule. The candidate must be able to work well with others in an informal results-oriented environment.
- Manufacturing technical support. Provide 24x7 on-call for manufacturing computer/automation/process control systems
- Monitoring and analysis of manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
- Developing and implementing technologies which enhance manufacturing operations
- Support implementation of projects of various magnitude to maximize success rates, reduce discrepancies, increase capacity/productivity, increase levels of safety and/or compliance
- Design and execution of large and/or strategic projects in line with overall department and plant strategies, including: project approach and resource needs, options analysis, execution plan, engineering document development, and system ownership through the project delivery life cycle of planning, design, implementation, installation, commission and qualification.
- Contribute towards infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes to increase efficiency and effectiveness of the Automation group. Candidate should have a mindset of sharing insights and improvements and participating in/lead design reviews.
- Ensure that systems achieve a high level of performance, reliability and regulatory compliance.
- Author and maintain detailed design documents, system architecture diagrams and standard operating procedures.
- Provide technical leadership, guidance and mentoring to staff including projects, continuous improvements and inspection/regulatory readiness initiatives.
- Assess and manage risks associated with system operation and use, and design, and implement improvements.
- Support site audits and inspections, and implement corrections as needed.
- This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents. As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
- B.S or M.S. in Chemical, Electrical or Mechanical Engineering or equivalent degree
- 5+ years of relevant work experience/training.
- Working experience supporting multiple controller platforms (such as Allen-Bradley PLC 5 & ControlLogix, Siemens, etc.) and interfaces (GE iFix, RSView, etc.), as well as historian and SQL/database experience.
- Experience at reviewing instrumentation and electrical wiring diagrams, communication networks, installation and troubleshooting.
- Theoretical and applied knowledge of process instrumentation, classical process control, continuous process control, Electrical areas and S88 Batch programming, validation and GMP regulations applicable to automated systems (including ISPE GAMP guidelines), ISA standards and P&ID nomenclature.
- Experience working in a cGMP environment
- Requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
- The successful candidate must have strong initiative and integrity as well as strong interpersonal, written and verbal communication skills. They should be able to successfully work independently and within teams, demonstrate strong problem-solving skills, partner/customer focus, and the ability to work with complex business systems and processes
- Flexibility for after-hours on call support rotation and support of 24/7 manufacturing operations
In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including:
- Competitive salary based on experience
- Aggressive bonus structure to reward your commitment
- Paid Time Off
- Company laptop
- Continuing education (internal and external)
- Health Insurance
- 401k plan with company match and discretionary annual profit sharing