Principal Automation Engineer

Company Description

Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

For more information, visit www.sequoiabiotech.com/.

Responsible for providing instrumentation and control engineering capabilities and expertise to the Engineering Group. Focus on providing long-term support for existing facilities with respect to the instrumentation and control systems for process, utility and building systems.

Job Responsibilities

Note: Essential responsibilities are presented in a logical order, emphasizing the time required and relative importance of tasks/activities. Each statement Incorporates relevant information to show level of independent judgment, physical/mental effort, complexity, leadership & supervisory responsibilities. Each bullet point begins with a present tense action verb. Proprietary names that change such as Xerox, Oracle or Gwiz are not used.

Essential

• Perform instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
• Produce and review design drawings, which may include Process Flow Diagrams, which incorporate mass balances, and Process &Instrumentation Diagrams which include all line sizing, instrumentation and control philosophies,
• Review design specification testing and perform field inspection services.
• Interact with vendors
• Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
• Play a lead role in the start-up and troubleshooting of process equipment and critical process utility systems.
• Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in existing facilities.
• Provide input into the validation of process equipment and associated utilities.

Supplementary Responsibilities

Note: Duties specific to groups or departments should be listed below.

• Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

Job Requirements

Education and Experience

• BS degree in Engineering (Chemical or Electrical preferred) and 10 years experience.

• or MS degree in Engineering (Chemical or Electrical preferred) and 8 years experience.
• Minimum of 7 year applicable instrument and control system experience.
• Minimum of 4 year in the pharmaceutical/biotech industry

Knowledge, Skills, and Abilities

• Practical knowledge of process, utility and building control systems.
• Practical knowledge of computer aided manufacturing automation.
• Practical knowledge of clean room or classified area design/requirements.
• Proficient Experience from a background of manufacturing, design or construction.
• Proficient knowledge of GMP guidelines, experience in generation of controlled documents
• Proficient Validation experience related to control and computer systems.
• Proficient knowledge of PID control theories and techniques.
• Proficient knowledge of programmable logic controllers, and associated programming languages.
• Proficient in ISA standards and practices for instrumentation.

• Demonstrate good organizational and time utilization skills.
• Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
• Demonstrate good written and verbal communication skills.
• Demonstrate strong working knowledge of PC based programs and systems.

• Ability to generate engineering drawings and specifications.
• Ability to interact closely with Process Engineering.
• Ability to maintain close working relationships with Maintenance, Manufacturing, Development, Validation and QA groups.

• Ability to invest time in excess of an 8-hour day or 40-hour week to expedite or complete assignments as required.
• Ability to work most of the time independently with no direct supervision.
• Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.

Work Environment/Physical Demands/Safety Considerations

Note: State work setting (manufacturing or office) and aspects of work that affect incumbents physically. If job requires lifting, ensure that maximum limit established by Safety department is not exceeded.

• Work in standard office environment.
• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
• When working in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
• May be exposed to hazardous materials and chemicals.

Signature Matrix

Legal Statement
Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.