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Mechanical Engineer IV

National Resilience

National Resilience

Other Engineering
Alachua, FL, USA
Posted on Wednesday, January 31, 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 Mechanical Engineer role is a GMP oriented position with substantial experience in Mechanical, Equipment, Process and Control systems pertaining to regulated BSL3/BSL2 Biomanufacturing facility, related product development labs, and warehouses. SME level competency is required on HVAC systems, Boilers, Heat exchangers, Compressors, Processes vessels, Process piping, Sterilizers, Parts washers, Bioreactors, Chromatography skids, equipment used for the production and distribution of clean utilities (USPW, WFI, Compressed gases) and various Buffers and Media. Experience working in GxP cleanroom environment in a regulated industry such as bio-pharmaceutical or medical device is required.

Job Responsibilities

  • Member of the Engineering Dept and perform the functions of a Responsible System Engineer (RSE) for assigned systems.
  • Lead, plan and execute the design, installation, qualification, operation, maintenance, and continuous improvement of mechanical systems as applied to BioPharma manufacturing facility (e.g.: HVAC systems, Boilers, Heat exchangers, Compressors, Processes vessels, Process piping, Sterilizers, Parts washers, Bioreactors, Chromatography skids, equipment used for the production and distribution of clean utilities such as USPW, WFI, Compressed gases and various Buffers and Media).
  • Generate, evaluate, gain approval for an execute continuous improvement projects to save labor, cost of materials, energy and waste in the facilities, production processes or utility systems.
  • Responsible for generating scope of work (SOW), Request for quote (RFI), process flow diagram, layout and detailed drawings for various Projects as required.
  • Technical lead for any issues which may arise in the mechanical, facility, process, and utility, and building infrastructure.
  • Assist other system owners in complex and cross-functional problem solving, project execution, risk reviews, quality events, maintenance, and re-certification, as needed.
  • Serves as Subject Matter Expert (SME) to support and lead assigned work orders, PMs, Maintenance orders and re-qualification.
  • Lead and support deviation investigations, root cause analysis, management of change, and CAPA identification and implementation of related corrective and preventives actions.
  • Lead optimization and improvements to cleanroom related equipment, infrastructure an related operations.
  • Develop SOPs, work instructions, test methods, requirement specifications and other design, operations, and maintenance documents.
  • Collaborate on the preparation/review of design documents, technology transfer protocols, facility fit assessments, risk assessments, as needed.
  • Draft, review, and/or execute user requirement specifications (URS), FRS, FAT, SAT, IQ, OQ, ES, and PQ protocols/reports supporting manufacturing process equipment and facility and infrastructure systems.
  • Ability and experience to work effectively in dynamic, cross-functional teams supporting Manufacturing, Quality Assurance, QC, R&D, PD, BD, EHS, and other departments, as needed.
  • Lead the collection and statistical analysis of equipment, process, and utility data through the use of Building Automation System (BMS) or other process automation platforms.
  • Skilled in troubleshooting of process/equipment systems, root cause and failure tree analysis, and quick turnaround of systems using emergency change controls and Engineering Change Proposal (ECP) and Management of Change (MoC).
  • Working knowledge and hardware and software understanding of PLC, MES, SCADA, Backup, and Access Control systems.
  • Operational understanding of Quality systems and Data Integrity requirements as it pertain to Biopharma/Pharma operations.
  • 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:
  • Facility Systems: HVAC systems, Boilers, Heat exchangers, compressors, hot and cold-water systems, chillers, freezers, cold rooms, and fire protection systems.
  • 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 (REES or Vaisala)
  • Process Equipment: Autoclaves, Washers, BSC, bioreactors, chromatography skids etc..
  • All other tasks as needed or assigned by supervisor.

Minimum Job Qualifications

  • Strong leadership and organization skills
  • Ability and willingness to learn and adapt skillsets to meet the changing need of various equipment and process systems.
  • Ability to perform well under pressure and tight timelines and maintenance.
  • Knowledge of cGMP compliance related to bioprocess drug substance manufacturing.

Preferred Job Qualifications

  • B.S in Mechanical, Chemical, Process or Automation engineering or in related fields
  • At least six (6) years of industry experience is in the preparation of cGMP documentation and supporting cGMP manufacturing.
  • Six (6) years of experience in a mechanical engineering, 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 decontamination systems.
  • Experience with bioprocess drug substance and drug product CGMP manufacturing.
  • Knowledge of regulatory compliance in pharmaceutical development.

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, operating motor vehicles, general observations of facilities, 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).

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

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

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 $105,000.00 - $138,750.00 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.