Process Engineer to Bohus Biotech AB

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 is an innovative company focused on the development and manufacture of high-quality products containing hyaluronic acid (HA). We are now in an expansive phase, investing in the products and processes of the future. We are looking for a driven Process Engineer who wants to become part of Bohus’s future and contribute to the continued development of hyaluronic acid and its products.

As our Process Engineer, you will be responsible for developing, optimizing, validating, and maintaining manufacturing processes to ensure product quality, process robustness, regulatory compliance, and operational efficiency. The role supports both existing production processes and the introduction of new products and technologies. You will be working closely with dedicated and highly competent colleagues within Production, Quality Assurance, Regulatory Affairs, Supply Chain, and R&D. You will get the exciting opportunity to build, shape and optimize our processes and apply your experience and expertise to ensure the highest manufacturing standards. If this sounds interesting to you - Come join us!

This is a full-time position and based in our company location in Strömstad, Sweden. On-site in Strömstad preferred, but hybrid solutions are possible for the right candidate. We will interview candidates continuously and welcome your application today.

Key responsibilities

The Process Engineer is responsible for ensuring that manufacturing processes are robust, efficient, validated, and compliant throughout the product lifecycle. You will bridge day-to-day manufacturing support with longer-term process development and operational excellence initiatives. The position reports to the COO.

Duties and responsibilities include:

• Develop, implement, and continuously improve manufacturing processes to enhance quality, yield, and efficiency.
• Lead root cause investigations and implement corrective and preventive actions (CAPA).
• Plan, execute, and document validation activities, including Process Validation, Equipment Qualification (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 structured problem-solving methods such as Root Cause Analysis, 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 and Competencies

The suitable candidate has the following qualifications:

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

The successful candidate for this position will be someone who:

• Has a strong technical and analytical mindset.
• Enjoys solving complex manufacturing and process-related challenges.
• Is structured and detail-oriented.
• Takes ownership and drives improvements independently.
• Communicates effectively across departments and organizational levels.
• Combines hands‑on problem solving with a systematic approach.
• Thrives in a fast‑paced environment where quality, compliance, and operational performance are equally important.

We offer a dynamic working environment with significant opportunity to make an impact — contributing to Bohus’s success as well as your own growth and development.

About Bohus Biotech

Founded in 1993, BOHUS has been at the forefront of Hyaluronic Acid (HA) development and manufacturing for over three decades. Our journey began with a vision to revolutionize the HA industry through innovation and commitment to excellence.

With more than 30 years of expertise, the company has established a strong international presence with products distributed to hospitals, clinics, and physicians in over 60 countries worldwide.

Bohus Biotech focuses exclusively on high quality hyaluronic acid technologies across three therapeutic areas:

• Ophthalmology – OVD solutions supporting tissue protection during cataract surgery
• Aesthetics – Dermal fillers based on the proprietary SHAPE technology platform
• Orthopaedics – Injectable treatments for osteoarthritis

All research, development, and manufacturing are located in Strömstad, Sweden, ensuring full control over product quality and innovation. For more information, visit the company's web sites at: www.bohusbiotech.com

For more information about this position, please contact:

Krishan Johansson Haque, PhD

Sr Recruitment Consultant, QRIOS Life Science & Engineering

T: [phone]

E: [e-mail]