Kyle Cross

Assembly Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Act as system owner for device assembly lines (e.g., auto‑injectors), defining assembly steps, tolerances, and in‑process controls for high‑speed operations.Plan and execute FAT/SAT covering feeding, joining, torque/force checks, and vision systems; confirm line balance and error‑proofing.Oversee installation/start‑up and integration with packaging/labeling modules; troubleshoot mechanical and control issues to meet yield and availability targets.Lead qualification and documentation (protocols, deviations, turnover packages), sustaining GMP compliance through ramp‑up. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in medical device assembly engineeringProven delivery of FAT/SAT, commissioning, and qualification with robust in‑process controls (vision, torque/force, error‑proofing) under GMP.Vendor and cross‑functional coordination skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Inspection Process Engineer - North Carolina - 12-month contract Join a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Own automated visual inspection systems for parenteral products, assuring detection capability, camera/lighting configurations, and data integrity meet quality targets.Lead FAT/SAT planning and execution, including defect kits, sensitivity studies, and false‑reject optimization.Coordinate installation/start‑up and connectivity with upstream/downstream equipment and MES/serialization where applicable.Maintain validation documentation, change control, and performance monitoring to sustain compliant release. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience with automated inspection technology and quality systems for sterile injectables.Demonstrated FAT/SAT, commissioning, and qualification in GMP environments, including defect library management and data integrity controls.Cross‑functional coordination and documentation excellence; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Formuation Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you’ll do: Own buffer preparation and compounding systems, translating process needs into equipment specifications and reviewing vendor drawings for cleanability, operability, and fit.Prepare and execute FAT/SAT and commissioning plans for vessels, transfer lines, and CIP/SIP interfaces; confirm materials of construction and sanitary design standards.Orchestrate site installation and start‑up with utilities, construction, and automation; verify recipes, sequences, and alarm philosophies support reliable operation.Lead qualification documentation and change control, ensuring traceability from design decisions to validated performance. What you’ll need: Previous experience serving as an Owner’s Representative.Extensive experience in process engineering with direct experience in buffer prep/compounding, sanitary design, and CIP/SIP.Proven ability to develop and execute FAT/SAT, commissioning, and qualification under GMP with robust recipe/phase logic.Strong stakeholder coordination and documentation discipline; full‑time on‑site presence in North Carolina. If this role is of interest, apply today!#LI-KC2

Filling Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Serve as system owner for syringe filling lines, driving design compliance, ergonomics, and throughput targets across machine centers and infeed/outfeed modules.Develop and run FAT/SAT protocols covering dosing accuracy, reject handling, and environmental controls; validate recipe/phase logic with automation.Manage installation, start‑up, and troubleshooting, coordinating vendors and plant teams to achieve stable, compliant operation.Prepare qualification packages and acceptance reports; resolve deviations and finalize turnover to operations. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in aseptic fill/finish engineering with hands‑on syringe or vial filling equipment and environmental control strategies.Track record delivering FAT/SAT, commissioning, and qualification under GMP, including recipe/phase verification.Strong problem‑solving, vendor management, and documentation skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Production Support Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you’ll do: Act as system owner for sterilization and cleaning assets (autoclaves, washers, stopper processing, clean equipment), steering vendor activities from design reviews through site installation and start‑up.Lead acceptance testing plans (FAT/SAT), define critical setpoints and verification checks; confirm equipment receipt, configuration, and readiness for qualification.Coordinate field integration with construction and automation teams so utilities, interlocks, and data capture align with manufacturing needs.Drive issue resolution and documentation (deviations, turnover packages), maintaining GMP‑compliant records through qualification and handover. What you’ll need: Previous experience serving as an Owner’s Representative.Extensive years in pharmaceutical/biotech process engineering with hands‑on exposure to sterilization and cleaning systems (autoclaves, washers, stopper prep).Demonstrated delivery of equipment through FAT/SAT, commissioning, and qualification under GMP.Strong cross‑functional coordination (construction, automation, validation) and excellent technical documentation skills; full‑time on‑site presence in North Carolina. If this role is of interest, apply today! #LI-KC2

Packaging Process Engineer - North Carolina - 12-month contractJoin a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.What you'll do:  Own secondary packaging lines (cartoning, labeling, serialization, case packing), ensuring design and documentation support compliant, traceable packaging flow.Develop FAT/SAT protocols and execute acceptance testing for coding/serialization, label reconciliation, and tamper‑evidence features.Coordinate installation/start‑up with warehouse/logistics interfaces and IT/serialization systems; stabilize line performance and resolve issues.Complete qualification records and change control; hand over a fully documented, validated packaging capability. What you'll need:  Previous experience serving as an Owner’s Representative.Extensive experience in packaging engineering for pharmaceuticals or medical devices, including serialization and label reconciliation.Demonstrated success delivering FAT/SAT, commissioning, and qualification under GMP with strong documentation standards.Effective cross‑functional coordination (quality, IT/serialization, logistics); full‑time on‑site presence in North Carolina. If this role is of interest, please apply today! #LI-KC2

Procurement Specialist - US, North Carolina - 12 Month ContractOur client, a global pharmaceutical manufacturing organization are looking for a talented Procurement Specialist to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States. What you'll do: Provide collaboration and input to subcontracting strategies to include bid lists, pre-qualification, compensation, award basis, risk management and other information to support commercial recommendations.Review and approval of subcontract award recommendations, change order requests, and other commercial actions to ensure compliance inclusive of negotiating and validating pricing and ensuring adherence of prime contract flow down terms and conditions.Review and monitor commercial action item requests and ensure timely processing.Collaborate with respective Building Project Managers (PMs) and Responsible Engineers/Work Package Owners (WPOs) to ensure the proposed scope and schedule are acceptable. What you'll need: Advanced knowledge of MS Excel, Word, PowerPoint, Adobe AcrobatPrevious experience in large-scale construction project work environmentsKnowledge of market researchBS in Logistics, Supply Chain Management, Business Administration or relevant field If you are interested, please apply now for immediate consideration and further information.#LI-KC2

C&Q Engineer - Subject Matter Expert - US, Philadelphia - 8 Month ContractDo you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this is the next step for you! One of our global pharmaceutical clients is currently requiring an experienced C&Q Engineer - Subject Matter Expert for their Philadelphia based location.   What you'll do: Report to the Client C&Q Manager.Develop and maintain detailed Commissioning Execution Plans in collaboration with C&Q firms, construction, automation, calibration, quality teams, system owners, and vendors.Author and review commissioning test documents, protocols, and project-specific procedures.Support schedule development, identify conflicts, and update commissioning timelines as plans evolve.Ensure team training requirements are identified and completed. What you'll need: Bachelor’s degree in Engineering (Electrical, Mechanical, Chemical, or Automation), Life Sciences, or related field.Extensive experience in CQV roles within cell and gene therapy, pharmaceutical, biotech, or medical device industries.Hands-on experience with automated systems in manufacturing environments.Proficiency with validation lifecycle tools and automation platforms.Excellent written and verbal communication skills. If this role is of interest to you, please apply now!#LI-KC2