BioSpace
Process Engineer II - 2nd shift (559)
BioSpace, Virginia State University, Virginia, us, 23806
About Civica
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Civica currently supplies medicines to health system members in 49 states and has partnerships with government agencies and payors to enable cost savings for customers. Civica’s mission includes CivicaScript to make quality outpatient generic medicines affordable and accessible. Civica is building a new state-of-the-art manufacturing facility and expanding into biologics to support GMP operations and capacity."
Job Description
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 includes a high-speed cartridge filling line, upgrades to critical utilities, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. The Senior Process Engineer will support startup, build a new organization, develop and implement systems and processes required to support GMP operations, and help establish site culture during the startup and growth phases. The Senior Process Engineer will act as a bridge between project planning and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. This role collaborates with Validation, Manufacturing, and Quality Assurance to ensure system availability, support, and lifecycle maintenance, and serves as a subject matter expert for regulatory inspections related to those systems. Essential Duties and Responsibilities
You must have a willingness to perform "hands-on" work in a dynamic, team-oriented setting. Provide technical expertise on CQV activities and ensure regulatory compliance, industry best practices, and engineering standards. Participate in the Engineering process to develop and institute technical and procedural controls in the process design. Accountable for CQV activity for assigned systems, including user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release. Execute engineering deliverables in a timely manner, plan details, and proactively pursue risks to avoid delays. Anticipate operational gaps and drive improvements to facility/equipment design and process efficiency to enable a smooth startup. Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and optimize processes using DMAIC and FMEA. Interpersonal skills to manage interactions across functions and with external system vendors. Basic Qualifications and Capabilities
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 analytical and problem-solving skills; able to deliver results on multiple complex assignments in a fast-paced environment. Ability to collaborate with Manufacturing, Automation, Quality Assurance, and R&D; capable of owning and following through on projects with minimal supervision. Willingness to adapt to changing priorities as project demands change. Preferred
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, formulation vessels, autoclaves, isolators with VPHP decontamination, and isolator glove and filter integrity testing). Direct experience ordering capital equipment, production materials, spare parts, and calibration/maintenance services. Familiarity with cleaning validation and/or process validation. Previous work at greenfield sites or substantial facility expansion projects. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Industries
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Petersburg, VA .
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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 includes a high-speed cartridge filling line, upgrades to critical utilities, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. The Senior Process Engineer will support startup, build a new organization, develop and implement systems and processes required to support GMP operations, and help establish site culture during the startup and growth phases. The Senior Process Engineer will act as a bridge between project planning and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. This role collaborates with Validation, Manufacturing, and Quality Assurance to ensure system availability, support, and lifecycle maintenance, and serves as a subject matter expert for regulatory inspections related to those systems. Essential Duties and Responsibilities
You must have a willingness to perform "hands-on" work in a dynamic, team-oriented setting. Provide technical expertise on CQV activities and ensure regulatory compliance, industry best practices, and engineering standards. Participate in the Engineering process to develop and institute technical and procedural controls in the process design. Accountable for CQV activity for assigned systems, including user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release. Execute engineering deliverables in a timely manner, plan details, and proactively pursue risks to avoid delays. Anticipate operational gaps and drive improvements to facility/equipment design and process efficiency to enable a smooth startup. Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and optimize processes using DMAIC and FMEA. Interpersonal skills to manage interactions across functions and with external system vendors. Basic Qualifications and Capabilities
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 analytical and problem-solving skills; able to deliver results on multiple complex assignments in a fast-paced environment. Ability to collaborate with Manufacturing, Automation, Quality Assurance, and R&D; capable of owning and following through on projects with minimal supervision. Willingness to adapt to changing priorities as project demands change. Preferred
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, formulation vessels, autoclaves, isolators with VPHP decontamination, and isolator glove and filter integrity testing). Direct experience ordering capital equipment, production materials, spare parts, and calibration/maintenance services. Familiarity with cleaning validation and/or process validation. Previous work at greenfield sites or substantial facility expansion projects. Seniority level
Mid-Senior level Employment type
Full-time Job function
Management and Manufacturing Industries
Internet News Referrals increase your chances of interviewing at BioSpace by 2x Get notified about new Process Engineer jobs in
Petersburg, VA .
#J-18808-Ljbffr