Process Engineer III (Relocation Assistance)

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Job description

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

Job Responsibilities

• Serve as owner and SME of Technology Transfer for biologics and vaccine manufacturing processes
• Perform site capability gap assessments and risk assessments to support the introduction of new manufacturing processes and products to the site
• Conduct process validation and troubleshooting to ensure consistent product quality and compliance with regulatory standards.
• Coordinates knowledge transfer from internal and external sending units.
• 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 and evaluate process performance
• Investigate manufacturing events and non-conformances to determine root cause and corrective actions
• Design studies to support investigative and optimization activities
• Provide technical support and training to manufacturing personnel.
• Ability to support continuous 24/7 operations, including assistance during nights and weekends as required.
• Supports process equipment on-boarding such as the drafting of user requirement specifications and drafting process equipment operational and maintenance Standard Operating Procedures (SOPs).
• Supports facility fit assessments of manufacturing processes in production suites.
• Ensure compliance with health, safety, and environmental, and cGMP regulations.
• May support other tasks as determined by management.

Minimum Job Qualifications

• Demonstrated process understanding one or more relevant product modalities (biologics, vaccines and gene therapy).
• Effective communication and interpersonal skills.
• Strong project management and organizational skills.
• Excellent problem-solving skills and the ability to think critically.
• Ability and willingness to learn and adapt skillsets for various areas of MS&T
• Demonstrated capability to work effectively and meet deadlines while delivering high-quality work.
• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.

Preferred Job Qualifications:

• Bachelor's degree in Biochemistry, Biochemical Engineering, or a related discipline.
• On-the-floor experience with upstream and/or downstream bioprocessing in a cGMP environment and/or experience within a process development laboratory.
• Experience using statistical software (JMP preferred)
• Experience with DoE and Process Characterization activities
• Experience with cleaning validation
• Experience contributing and/or leading cross-functional teams to support company objectives
• Knowledge of LEAN Manufacturing and Six Sigma methodologies.

Role/Site Specific Requirements:

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.

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