Automation Engineer

COMPANY DESCRIPTION:

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form 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.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW:

Sequoia is seeking an experienced Automation Engineer with MES implementation experience, knowledgeable in instrumentation and control engineering design services for existing facility projects. This role involves automation with CSV, life cycle documents, automation SDLC network and IT infrastructure, and distributed control systems including historian and batch software.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Perform instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
• Lead the planning and implementation of MES projects, with a focus on electronic batch records.
• Produce and review design drawings, which may include Process Flow Diagrams incorporating mass balances, and Process & Instrumentation Diagrams including all line sizing, instrumentation, and control philosophies.
• Review design specification testing and perform field inspection services.
• Interact with vendors and review/approve vendor information packages, including drawings and specifications, 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.
• Support the work of the Engineering Group, including research/evaluation of instrumentation and control components, and review/modify control system concepts/logic as a result of troubleshooting.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• BS degree in Engineering (Chemical or Electrical preferred) and 8 years of experience, or
• MS degree in Engineering (Chemical or Electrical preferred) and 6 years of experience.

Technical Experience:

• 8 years of applicable instrumentation and control system experience.
• 5 years in the pharmaceutical/biotech industry with GMP experience.
• Proven experience in MES implementation, specifically for electronic batch records.
• Practical knowledge of computer-aided manufacturing automation.
• Practical knowledge of process, utility, and building control systems.
• Practical knowledge of clean room or classified area design/requirements.
• Practical knowledge of GMP guidelines and experience in generating controlled documents.
• Practical knowledge of PID control theories and techniques.
• Proficient in ISA standards and practices for instrumentation.
• Proficient knowledge of programmable logic controllers and associated programming languages.
• Validation experience related to control and computer systems.
• 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 strong working knowledge of PC-based programs and systems.
• Demonstrate good written and verbal communication skills.
• 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 comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
• Ability to work most of the time independently with no direct supervision.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

The expected salary range for this position is $97,000 to $115,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Applicants must have current work authorization when accepting a position at Sequoia. Currently, Sequoia is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT:
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.