Engineer, MSAT Upstream

About the role

As an Engineer, MSAT Upstream at Avid Bioservices, you will be the main point of contact for clients and internal departments, providing technical support and ensuring successful transfer and execution of new upstream processes in manufacturing. You will collaborate with clients on upstream process status, troubleshoot issues on the floor, and drive process improvement to increase efficiency and decrease risk.

Responsibilities

• Develop and cultivate positive client and internal Avid group partnerships.
• Communicate with clients on process status and collaborate to resolve issues on the floor.
• Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
• Author Manufacturing Batch Production Records, technical reports, and Process Validation Protocols.
• Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale and conduct equipment and facility fit assessments for new processes or process changes.
• Monitor process health through process monitoring and author technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.
• Provide technical training to Upstream Manufacturing Operators and assist in CAPA investigations and recommend dispositions.
• Conduct systematic investigations of root causes or problems or identified risks and evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.
• Other tasks as assigned.

Requirements

• Bachelor’s degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
• 2+ years of biologic upstream manufacturing experience.
• Strong understanding of cGMPs or equivalent standards and ability to make sound decisions to resolve or escalate deviations and/or issues on the production floor.
• Ability to oversee a project from start to finish with little to no supervision.
• Track record of strong leadership.
• Hands-on experience with cell culture process and aseptic techniques.

Qualifications (Preferred)

• Master’s degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
• Hands-on experience with Upstream process equipment including, but not limited to: Large scale single use bioreactors (100L and up), Wave technology, Harvest technology (3M, Millistak, and/or centrifuge), and DeltaV software.

Skills

• Exceptional written and verbal communication skills.
• Strong multitasking abilities and attention to detail.
• Ability to build and maintain relationships with team members, clients, vendors, or suppliers.
• Positive attitude and team-oriented approach.

Benefits

• Health, dental, and vision insurance.
• 401(k) matching.
• Paid time off.
• Performance-based bonuses.
• Opportunities for career growth and development.
• Supportive and inclusive work environment.

Pay

The compensation range for this role is $95,200 - $119,000 annually, depending on experience and qualifications.

Schedule

This is a full-time position, Monday through Friday. The employee must be available to work overtime, weekends, and/or holidays when necessary.

Physical Demands & Work Environment

• Regular activities include sitting, standing, and walking.
• Occasional physically engaging tasks such as lifting objects up to 25 pounds.
• Potential exposure to electrical shocks, toxic chemicals, vibrations, or loud noise levels.
• Essential visual acuity, including close, distance, and color vision.

Reasonable accommodations are available to enable individuals with different abilities to perform effectively.