Process Engineer III

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary
The Process Engineer III is experienced with biological manufacturing platforms for impacting global health initiatives. The individual will have the desire to grow in both personal and professional areas of competence. The Process Engineer III is responsible for the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing. This position will work cross-functionally to define the manufacturing processes for current Good Manufacturing Practice (cGMP) production.

Responsibilities

• Serve as project lead and/or principal investigator of projects to establish cGMP operations in clinical and commercial manufacturing.
• Leads the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and drug products.
• Leads process validation and troubleshooting to ensure consistent product quality and compliance with regulatory standards.
• Design and implement new process technologies and equipment.
• Conduct thorough analysis of existing processes to identify areas of improvement.
• Lead and manage process improvement projects from conception through to implementation.
• Prepare and present project status reports to stakeholders.
• Coordinates the information transfer and gap assessment of new processes and method transfers.
• Prepare and maintain GMP documents, including batch records, material specifications, sampling plans, and SOPs.
• Collaborate with cross-functional teams, including Process & Analytical Development, Quality Assurance, and manufacturing, to support process development, technology transfer, and manufacturing activities.
• Analyze process data to identify trends, perform root cause analysis, and implement corrective and preventive actions.
• Provide technical support to production teams for troubleshooting process-related issues.
• Participate in safety and regulatory audits and implement corrective actions as needed.
• Perform and document investigations related to manufacturing processes.
• Supports process equipment on-boarding such as the drafting of user requirement specifications and drafting process equipment operational and maintenance Standard Operating Procedures (SOPs).
• Support the coordination of process equipment movement and readiness check based on manufacturing forecasting.
• Supports the material forecasting of process materials and equipment.
• Leads facility fit assessments of manufacturing processes in production suites.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
• Ensure compliance with health, safety, and environmental, and cGMP regulation.
• Serve as project lead and/or principal investigator of projects to establish cGMP operations in clinical and commercial manufacturing.
• Supports the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and products.
• Coordinates the information transfer and gap assessment of new processes and method transfers.
• Writes protocols and facility fit reports for the on-boarding and transfer of manufacturing operations in cGMP manufacturing suites.
• Uses change controls and corrective and preventative actions (CAPAs) to document cGMP changes and new controls.
• Provide coaching and training for junior engineers, fostering their growth and skill development.
• Prepares unit operation bill of materials (BOMs) and drafting of BOMs for production planning and manufacturing.
• Ability to support continuous 24/7 operations, including assisting during nights and weekends as required.

May support other tasks as determined by management.

Minimum Qualifications

• Demonstrated process understanding of at least one manufacturing platform supporting drug substance production and purification using adherent or suspension cell culture; or successful experience in the implementation of a drug product manufacturing process.
• Demonstrated ability to create clear, concise, and comprehensive technical documentation.
• Excellent problem-solving skills and the ability to perform root cause analysis.
• Demonstrated capability to work effectively under tight deadliness and under pressure, ensuring high-quality outcomes.
• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes (Drug Substance and Drug Product)
• Experience in two or more of the following:
  • Cell Culture (fermentation, adherent, suspension)
  • Chromatography
  • TFF (UFDF)
  • Viral Inactivation
  • Viral Filtration
  • POD Filtration
  • Clarification
  • Harvest
  • Aseptic Technique

Preferred Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, molecular biology, or a related discipline.
• Five (5) years of experience with drug substance and drug product manufacturing process development and cGMP manufacturing with upstream and/or downstream bioprocessing
• Technical expertise in aseptic processing and Cleaning Validation
• Knowledge of LEAN Manufacturing and Six Sigma methodologies
• Effective communication and interpersonal skills.
• Strong project management and organizational skills.
• Ability and willingness to learn and adapt skillsets based on business needs

This position may also include the following:

· This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.

· Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, etc.

· Participation in an occupational health program which can include medical assessment, surveillance, vaccination, and testing.

· Use of personal protective equipment which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.

Exposure to the following:

· Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

· Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens

· Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.

· Packaging, transporting, and shipping of infectious or potentially infectious substances

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.