Process Development Engineer

Kuros Biosciences, Inc.; Tipton; On-site; GBP 65,000 - 68,000; Full time

Job summary

A dynamic biotech company based in the UK is seeking a Technical Manufacturing Engineer to lead process development, ensure compliance with quality regulations, and support the launch of new manufacturing operations. The ideal candidate will have robust experience in manufacturing engineering and a proven track record in process validation. This full-time role requires strong leadership and problem-solving skills, alongside a solid educational background in engineering.

Qualifications

• 3+ years in Manufacturing, Process or Quality Engineering in an ISO13485-regulated industry.
• Experience performing IQ, OQ, PQ validations.
• Understanding of compliance with regulatory and safety standards (GMP, ISO, FDA).

Responsibilities

• Support the building of manufacturing facility in Alpharetta, Georgia.
• Validate and qualify manufacturing equipment and processes.
• Create and optimize manufacturing processes to improve efficiency and quality.
• Ensure compliance with medical device quality system requirements.
• Manage and allocate team resources across multiple projects.

Skills

Strong analytical and problem-solving skills

Excellent communication and interpersonal abilities

Proficiency in process control, lean methodologies and Six Sigma tools

Proficiency in data analysis tools (Minitab, PowerBI, Tableau)

Experience in developing Supplier Quality programs

Experience with regulatory environments (GMP, FDA, ISO)

Education

Bachelor’s degree in Engineering, Biology or a related field

Lean Six Sigma Green Belt or Black Belt Certification

Tools

Minitab

PowerBI

Tableau

Microsoft Dynamics 365

Job description

Contribute your technical manufacturing, leadership, and project management skills to a dynamic and fast-growing biotech company. This key technical role will have responsibilities in supporting Kuros' manufacturing by creating and validating manufacturing processes, managing continuous improvement initiatives, authoring all associated manufacturing documentation, and maintaining compliance with our quality system. This role will lead to the design, optimization, and scale-up of manufacturing processes and is critical to ensuring efficient, safe, and high-quality production. This is a full‑time, on‑site position.

Key Responsibilities

• Join a core team of leaders to support the building of Kuros’ newest manufacturing facility in Alpharetta, Georgia.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
• While utilizing Lean manufacturing tools, create, maintain and improve production processes, refining BOMs, workflow processes, PFMEAs and detailed work instructions.
• Create, design, develop and optimize manufacturing processes to improve efficiency, yield, and product quality.
• Establish group and individual objectives, priorities, and metrics.
• Ensure fulfillment of product development goals for Kuros projects.
• Ensure production of products meets expected output.
• Ensure quality requirements are fulfilled and maintained.
• Maintain compliance with medical device quality system which includes leading and/or supporting corrective action preventative action initiatives (CAPAs), discrepant material disposition and implementation of Engineering Changes.
• Develop and maintain detailed process documentation, including process flow diagrams (PFDs), SOPs and batch records.
• Ensure compliance with regulatory and safety standards (e.g., GMP, ISO, FDA, EH&S).
• Support capital projects from concepts through commissioning and validation.
• Evaluate, select and implement equipment and technology upgrades.
• Lead process development for new and existing products and support scale‑ups from R&D to full production.
• Preventive maintenance of equipment and utilities and troubleshoot if needed.
• Provide technical support for failure analysis and root‑cause investigation of product failures.
• Identify and implement continuous improvement projects with respect to first‑pass yield, cycle‑time reduction, product reliability, capacity enhancement and cost reduction, utilizing a DMAIC and DMADV structure.
• Plan, budget and staff projects, tracking performance throughout.
• Manage and allocate team resources over multiple projects.
• Provide and solicit resources to and from other teams as necessary.
• Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF) and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
• Improve product quality, yield and reduce costs.
• Analyze instrument‑manufacturing lines from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Provide production line support for day‑to‑day engineering issues on core equipment.
• Provide technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.

Qualifications

• Education
  • Bachelor’s degree in Engineering, Biology or a related field required. Master’s degree or MBA preferred.
  • Lean Six Sigma Green Belt or Black Belt Certification preferred.
• Experience
  • 3+ years in Manufacturing, Process or Quality Engineering in an ISO13485‑regulated industry.
  • Experience with regulatory environments such as GMP, FDA or ISO standards.
• Skills
  • Strong analytical and problem‑solving skills.
  • Excellent communication and interpersonal abilities.
  • Proven experience in performing IQ, OQ, PQ.
  • Proficiency in process control, lean methodologies and Six Sigma tools.
    • Experience in identification of the 8 wastes, line balancing and performing theory of constraints.
    • Experience in developing and sustaining morning markets and value‑stream structure organization.
    • Experience in performing Gage R&R, attribute agreement analyses and MSA.
    • Experience in performing Cpk Analyses for either in‑process or incoming inspections.
  • Proficiency in data analysis tools and software such as Minitab, PowerBI, Tableau.
  • Proficiency in ERP and master data, preferably in Microsoft Dynamics 365.
  • Experience in developing and sustaining a Supplier Quality program that monitors supplier performance using KPIs such as PPM, SCAR and OTD.
  • Experience in developing and continuously improving Quality KPIs such as First Pass Yield, NCR, Inventory Accuracy and monitoring budget to fiscal‑year plan.

Travel Requirement

• Ability to travel domestically and internationally.

Pay Range

$87,000 - $90,000 USD

Physical Requirements and Work Conditions

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending or stooping.
• Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping and operating office or job‑specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.

Specific requirements may vary by role. Contact an HR representative for details related to the position.

Our credentials

• Listing on SIX Swiss Exchange under the symbol KURN since 2016.
• A commercial & research footprint that spans >20 markets.
• 4 teams of internationally renowned clinical and scientific expert advisers.
• >25 orthobiologics‑related patents.
• >400 patients evaluated in Level I, randomized controlled clinical trials.
• >20 well‑controlled Level I‑IV clinical trials initiated, including 6 that are complete.
• Published Level I evidence published in Spine.

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.

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