Process Engineer II
4 weeks ago
About BioSpace, Inc.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
The organization has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter.
The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics.
Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.
The successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.
Key Responsibilities:
- Provide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.
- Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
- Accountable for CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
- Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
- Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
- Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
Requirements:
- Bachelor's degree in Engineering required.
- Strong mechanical aptitude.
- Demonstrated ability to solve technical problems and implement projects.
- Excellent interpersonal and communication skills, and fluency in English.
- Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
- Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.
- Willingness to adapt to changing priorities as project demands change.
Preferred Qualifications:
- 5+ years of experience in sterile injectables, drug-device combination products, or biologics.
- SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment - vials, pre-filled syringes, and cartridges - isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).
- Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
- Familiarity with cleaning validation and/or process validation.
- Previous work at greenfield sites or substantial facility expansion projects.
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