Process Engineer, Biotech Manufacturing & Validation

QRIOS; Strömstads kommun; Hybrid; SEK 650,000 - 900,000; Full time

Job summary

Bohus Biotech seeks a driven Process Engineer to develop, optimize, validate, and maintain manufacturing processes for HA products in a regulated setting. You will collaborate with Production, QA, Regulatory Affairs, Supply Chain, and R&D to ensure quality and efficiency.

Based in Strömstad, Sweden, this on-site role offers hybrid options for the right candidate. Join a fast-growing team focused on high manufacturing standards and continuous improvement.

Qualifications

• Formal academic degree level (BSc. or MSc.) in chemical engineering, biotechnology, pharmaceutical science or related.
• Strong background in process engineering preferably with validation engineering experience.
• Experience in a regulated industry (e.g. Medical Devices, Pharmaceuticals, Biotechnology).
• Experience with sterile processes, IQ/OQ/PQ, process validation, troubleshooting, and continuous improvement would be highly valuable.
• Experience with Quality Management Systems.
• Knowledge of statistical analysis and process capability concepts.
• Excellent communication and documentation skills in English are required

Responsibilities

• Develop, implement, and continuously improve manufacturing processes to enhance quality, yield, and efficiency.
• Lead root cause investigations and implement CAPA.
• Plan, execute, and document validation activities, including Process Validation, IQ/OQ/PQ, Cleaning Validation, and Test Method Validation/Verification.
• Provide technical support to production, investigating process deviations, non-conformities, and out-of-specification results.
• Lead continuous improvement initiatives using RCA, FMEA, and 5 Why.
• Ensure processes comply with ISO 13485, EU MDR 2017/745, ISO 14971, and GMP principles.
• Support audits and inspections by customers, regulatory authorities, and Notified Bodies.
• Support technology transfers from R&D to production and participate in cross-functional development projects.
• Approve process validation documentation according to delegated authority and elevate process risks impacting product quality, compliance, or supply.

Skills

Process engineering

Validation engineering

Regulated manufacturing

Statistical analysis

Quality systems

English communication

Problem solving

Cross-functional teamwork

Education

BSc or MSc in chemical engineering

Tools

IQ/OQ/PQ

CAPA management

GxP documentation

Statistical software

Job description

Bohus Biotech seeks a driven Process Engineer to develop, optimize, validate, and maintain manufacturing processes for HA products in a regulated setting. You will collaborate with Production, QA, Regulatory Affairs, Supply Chain, and R&D to ensure quality and efficiency.

Based in Strömstad, Sweden, this on-site role offers hybrid options for the right candidate. Join a fast-growing team focused on high manufacturing standards and continuous improvement.