Sr Automation Engineer
Sr Automation Engineer
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$ 114000 - 150000
1 Vacancy
Job Description
COMPANY DESCRIPTION:
SynerG 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 lifesaving 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.
SynerG BioPharma Group was recently honored with BioSpaces prestigious Best Places to Work 2025 award for the second consecutive year along with many other awardwinning programs to make a career here truly lifeenhancing. 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 SynerG 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/ or www.Synergbiopharma
POSITION OVERVIEW:
Sequoia is seeking an experienced Automation Engineer with validation experience knowledgeable in mRNA and LNP equipment and processes to assist with but not limited to 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.
- Evaluate various processes to implement optimal configuration changes.
- Oversee and assist in the development and review of System Integration Design Specifications for the integration of thirdparty equipment.
- Execute the implementation of application software device interface and system integration designs.
- Lead the development review and of Module Integration and Customer Acceptance Tests protocols which cover the testing of the application software device interface and system integration implementation.
- Assist with installation commissioning and startup system upgrades and continued process improvement.
- Implement control methodology in DCS PLC or HMI platforms with a high level of understanding of various programming languages.
- Work crossfunctionally with Quality Regulatory and Manufacturing organizations. May act as a representative in multidisciplinary project teams and present data when necessary.
- Provide technical leadership for the of projects.
- Ensure compliance with cGMP regulatory and industry standards.
- Knowledgeable in mRNA and LNP equipment and processes.
- Experience with site startup projects and technical background in Manufacturing Science & Technology (MS&T) Engineering Process Development and Manufacturing.
- Development of novel circular mRNA purification and LNP formulation platform for delivery of highly pure drug substance.
- Cell/Gene Therapy production experience in GMP R&D and Operations is a MUST.
- Spec equipment order setup troubleshoot and maintain nucleic acid production purification and characterization equipment for optimal RNA workflow.
- Experience with downstream purification unit operations column chromatography column packing tangential flow filtration (TFF) depth filtration and continuous manufacturing.
- Design lead and drive experiments for screening optimization and scaleup purification of RNA.
- Knowledge of mRNA processes and upstream process equipment (TFF Chromatography).
- Startup experience with process equipment.
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/MS in Engineering or a relevant subfield of engineering.
Technical Experience:
- Minimum 5 years of related engineering and/or technical experience required.
- 47 years of relevant experience within the biotech industry with proven knowledge of current Good Manufacturing Procedures (cGMP) compliance.
- Proficient understanding of analog advanced control and batch control.
- Proficient knowledge of P&IDs and instrumentation/control equipment in an industrial environment.
- Understanding of the control methods analog and discrete and the critical components to developing sustainable control algorithms.
- Demonstrate leadership in loop checking startup troubleshooting and commissioning support in an industrial environment.
- Proficient ability to understand control philosophy and write functional requirement specifications.
- Strong leadership collaboration communication prioritization and problemsolving skills.
- Highly motivated independent detailoriented team player with good organization initiative and a collaborative attitude is essential.
Knowledge Skills and Abilities:
- Excellent computer verbal and written communication skills.
- Innovative problemsolving skills and an integrated view of business/scientific issues.
- Accountable and responsible individual to perform as intended for clients.
- Willingness to travel to various clients when needed with acceptable limitations during noted health pandemics or related constraints.
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 companypaid 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 $114000 to $150000. Actual pay will be determined based on experience qualifications geographic location and other jobrelated 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:
SynerG 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 employees race color creed religion sex pregnancy or childbirth personal appearance family responsibilities sexual orientation or preference gender identity political affiliation 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. SynerG BioPharma is an EVerify employer.
Required Experience:
Senior IC
Employment Type
Full Time
