Be an early applicantLess than 25 applicantsPosted by Agency
The Job Network ยท 3 days ago
Process Engineer II
Petersburg, VA
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Provide technical expertise on CQV activities and ensure 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.
Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
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.
Qualification
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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
The Job Network
TheJobNetwork is a leading recruitment advertising network that connects employers and qualified talent across hundreds of trusted local and niche publisher job sites that are powered by RealMatch, Inc.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
