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Civica Rx · 4 months ago

Process Engineer II - 2nd shift (559)

Petersburg, VA

Full-time

Onsite

Mid, Senior Level

5+ years exp

Civica Rx is a market-based nonprofit focused on preventing and mitigating drug shortages in the U.S. healthcare system. The Process Engineer II will be instrumental in preparing the Petersburg, VA facility for production and supporting the startup of a new biologics manufacturing expansion, ensuring compliance and operational efficiency throughout the process.

Pharmaceutical

H1B Sponsor Likely

Responsibilities

You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting

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

Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors

Qualification

CQV activitiesGMP operationsDrug product processingMechanical aptitudeAnalytical skillsInterpersonal skillsCommunication skillsProblem-solving skillsTeam-orientedAdaptability

Required

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

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

Company

Civica Rx

Glassdoor3.2

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

Founded in 2018

Lehi, Utah, USA

51-200 employees

https://civicarx.org/

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (2)

2022 (1)

2021 (2)