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Company

Original Job Post

BioSpace · 6 days ago

Process Engineer II

Petersburg, VA

Full-time

Onsite

Mid, Senior Level

5+ years exp

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Comp. & Benefits

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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.

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

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Mechanical AptitudeProject ImplementationFluency in EnglishCross-functional CollaborationProblem-SolvingInterpersonal SkillsCommunicationAnalyticalSelf-DirectedAdaptabilityTeamworkSterile InjectablesBiologicsDrug-Device Combination ProductsDrug Product Processing EquipmentSingle-Use MixersStainless Steel Formulation VesselsParts WashersAutoclavesComponent ProcessorsAseptic Filling EquipmentVialsPre-Filled SyringesCartridgesIsolatorsVHP DecontaminationFilter Integrity TestingIsolator Glove Integrity TestingCapital Equipment OrderingMaterial Procurement

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.