hero

Join TechBio Companies Driving Patient Impact

Sponsored by Alix Ventures

Post a job // Join our newsletter
BIOS Community
BIOS Community
309
companies
1,962
Jobs

Process and Critical Systems Engineer II

National Resilience

National Resilience

Software Engineering
Alachua, FL, USA
Posted on Wednesday, May 22, 2024

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 & Role

The Process & Critical Systems Engineer should be a GMP oriented individual with experience in cleanroom operation, process equipment (upstream and downstream processes, autoclaves, washers, bioreactors, chromatography skids, clean utilities etc.) and utility systems design, installation, qualification, operation, maintenance, and continuous improvement. Experience working in a GxP cleanroom environment in a regulated industry such as bio-pharmaceutical or medical device is required.

Job Responsibilities

  • Member of the Process Engineering team and perform the functions of a Responsible System Engineer (RSE)
  • Seek for time or money saving efforts in production processes or utility systems
  • Responsible for generating room equipment layout and utility assessment for Projects
  • Technical lead for any issues which may arise in the cleanroom infrastructure and related utilities
  • Responsible system engineer for process and process waste systems (Autoclave, Washers, Waste Neutralization, EDS, Room Decontamination)
  • Assist other system owners in complex and cross-functional problem solving
  • Serves as SME
  • Serves as Subject Matter Expert (SME) to support assigned work orders and Quality Systems. Support deviation investigations, root cause analysis, and CAPA identification and implementation
  • Lead optimization and improvements to cleanroom operations and infrastructure
  • Develop SOPs, work instruction, test methods, requirement specifications and other design, operations, and maintenance documents
  • Collaborate on the preparation/review of design documents, technology transfer protocols and facility fit assessments.
  • Draft, review, and/or execute user requirement specifications (URS), FAT, SAT, IQ, OQ, ES, and PQ protocols/reports supporting manufacturing process equipment and infrastructure systems.
  • Experience and ability to work in cross-functional dynamic teams supporting Manufacturing, Quality, Assurance, R&D, and other departments as needed
  • Lead Statistical analysis of process and utility data through use of Building Automation System
  • All other tasks as needed or assigned by supervisor
  • Skilled in root cause analysis and troubleshooting of process/equipment systems
  • Basic understanding of PLC, MES, SCADA systems
  • Ability to read, review and redline process flow diagrams and P&IDs.
  • Experience leading and supervising system installations and Capex projects including managing contractors.
  • Provide technical feasibility assessment and develop proposals for future systems and facility expansions.
  • Well versed in implementing and following safety, health, and environmental requirements as applied to biopharma industry.
  • Systems which this person will interact and support as Process & Critical Systems Engineer will include but are not limited to:
    • Plant Utilities: domestic water, lab water, soft water, boilers, chillers, air compressors, air handling units, electrical systems, fuel, and natural gas
    • Clean Utilities: USP high purity water, water for injection, clean steam, clean compressed air, lab and manufacturing gas systems
    • Automation: building automation system (BAS), SCADA, alarm monitoring system (REES0(Vaisala)
  • Process Equipment: Autoclaves, Washers, BSC, bioreactors, chromatography skids etc.

Minimum Qualifications

  • Extensive experience in the capacity of process and/or critical system engineer supporting cGMP manufacturing in a regulated industry such as biopharma.
  • Strong leadership and organization skills
  • Ability and willingness to learn and adapt skillsets for various areas of MS&T and Engineering.
  • Ability to perform well under pressure and tight timelines with maintenance.
  • Knowledge of cGMP compliance around bioprocess drug substance manufacturing.

Preferred Qualifications

  • B.S in chemical engineering, pharmaceutical sciences or related field + 6 years industry experience or MS + 4 years industry experience
  • Extensive experience in a process engineering role or manufacturing role within the biotech/bio-pharmaceutical manufacturing industry
  • Technical expertise in upstream / downstream operations including equipment knowledge and processes, including but not limited to disposable technologies, clarification holders and devices, chromatography skids, TFFs, formulation processes, final fill.
  • Technical expertise in Autoclave, washers, effluent decontamination systems, and room decontaminations systems.
  • Experience with bioprocess drug substance manufacturing CGMP manufacturing.
  • Knowledge of regulatory compliance in pharmaceutical development.

Role and Site-Specific Requirements

  • 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, operating motor vehicles, general observations of facilities, 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:
    • Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
    • 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.
    • Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
    • Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
    • Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
    • Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

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 $70,000.00 - $96,250.00 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.