Process Engineer

Full Time Role: Process Engineer

Location: Leeds, United Kingdom

About the role:

Lead the end-to-end supply chain and launch execution for New Product Introduction (NPI) programs. Design and implement robust value chains and manufacturing solutions that meet business objectives, regulatory and quality standards, and safety/EHS requirements while driving cost-efficiency and on-time delivery.

Key Responsibilities:

• Own end-to-end supply chain design and execution for NPI programs, ensuring alignment with business strategy and cross-functional stakeholders.
• Define and optimize the value chain for new products, including sourcing, BOM development, routings, and production documentation.
• Coordinate cross-functional launch activities using standardized launch management tools to deliver projects on schedule and within budget.
• Lead equipment design, validation, and process improvement projects to increase manufacturing efficiency, reliability, and compliance.
• Plan, execute, and document IQ/OQ/PQ activities for new equipment and processes.
• Support regulatory submissions with clear technical writing, data analysis, and documentation to facilitate approvals.
• Ensure adherence to regulatory, quality, EHS, and safety policies throughout development and scale-up.
• Identify and implement cost-reduction and manufacturability opportunities for product designs and processes.
• Drive resolution of NCRs, CAPAs, audit observations, and safety/ergonomics actions in collaboration with quality and operations teams.
• Provide engineering and operational support across departments for critical issues and continuous improvement initiatives.
• Apply the project management methodologies to manage scope, schedule, risk, and budget; communicate status to stakeholders.

Qualifications:

• Bachelor’s degree in Engineering, Supply Chain, Manufacturing, or related field; advanced degree preferred.
• 5+ years experience in NPI, manufacturing engineering, supply chain, or project leadership within regulated industries (pharmaceutical, medtech, biotech, or similar).
• Proven experience with equipment validation and IQ/OQ/PQ protocols.
• Demonstrated knowledge of regulatory and quality systems (e.g., GMP, ISO) and EHS practices.
• Strong project management skills; PMP or equivalent certification is a plus.
• Track record of leading cross-functional teams and delivering complex launches on time and on budget.

Skills & Competencies:

• Technical problem solving and process improvement (Lean, Six Sigma desirable).
• Excellent written and verbal communication; effective technical writing for regulatory submissions.
• Data-driven decision making and proficiency with production documentation/BOM management tools.
• Strong stakeholder management and ability to influence across functions.
• Detail-oriented with a focus on compliance and product quality.

Mail to: info_upshot@upshotengineering.com