Process Engineer

Syner-G Bio Pharma 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.

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.

Sequoia is seeking an experienced Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes.

KEY RESPONSIBILITIES :

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
• Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
• Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
• Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.
• Provide technical support for the product/process lifecycle and related activities.
• Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
• Provide support for improvement projects regarding processes and systems.
• Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
• Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
• Analyze and recommend improved technology to increase quality and efficiency.
• Provide technical analysis and support for new or improved process systems.
• Facilitate and schedule meetings with subject matter experts across the organization.
• Ensure compliance with cGMP, regulatory, and industry standards.

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:

• Bachelor’s degree in Engineering, Bio/Pharma Science, or a related technical field of study.

Technical Experience:

• 4-7 years of related engineering and/or technical experience required.
• Experience with cGMP Manufacturing within an FDA-regulated manufacturing company.
• Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company.
• Knowledge of FDA regulations and guidance or applicable regulatory standards and practices.
• Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client.
• Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc.
• Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer.
• Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers.

Knowledge, Skills, and Abilities:

• Excellent computer, verbal, and written communication skills.
• Innovative problem-solving 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:

• While performing the duties of this job, the employee is…