We are supporting a leading pharmaceutical company in the search for a Manufacturing Engineer who will take ownership of critical manufacturing processes and drive continuous improvement across a highly regulated production environment. This is an exciting opportunity for an engineer with a passion for innovation, problem-solving, and operational excellence. This is a 5-month consultancy assignment based in Uppsala.

Key Responsibilities

• Act as the technical owner for designated process areas, overseeing lifecycle management including upgrades and obsolescence mitigation.

• Lead small to medium-sized process and equipment improvement projects from concept to implementation, including change control, validation, and technical documentation.

• Drive continuous improvement initiatives using Lean and Six Sigma methodologies to improve yield, reduce downtime, and optimize OEE.

• Develop, monitor, and improve productivity KPIs using data analytics and statistical tools to ensure sustained process performance.

• Lead root cause investigations using structured problem-solving methods (5 Whys, Fishbone, 5M, etc.) aligned with J&J Non-Conformity and CAPA processes.

• Plan and execute equipment and process validation activities in accordance with GMP, ISO 13485, and FDA 21 CFR Part 820, including Computerized System Validation when applicable.

• Collaborate closely with R&D, Quality, and Supply Chain to support technology transfer, automation initiatives, and Design for Manufacturability and Assembly (DFMA).

• Foster a culture of innovation, safety, and continuous improvement within the manufacturing organization.

Qualifications

• BSc or MSc in Material Science, Mechanical, Electrical, Industrial Engineering, or a related technical field.

• Minimum 2 years of experience in manufacturing or industrial engineering within a regulated industry (Medical Device or Pharmaceutical preferred).

• Solid understanding of change control and equipment/process validation (URS, FAT, SAT, IQ, OQ, PQ, CSV).

• Knowledge of automation systems, data analytics, and process troubleshooting.

• Working knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820.

• Analytical, structured, and proactive with strong ability to manage multiple priorities.

• Fluency in English and Swedish.

Start: January 2026
Duration: 5 months
Location: Uppsala 

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