Experienced Senior Computer System Validation Engineer to Sever Pharma Solutions

Job Description: We are seeking an experienced Senior Computer System Validation Engineer to join our team. You will play a key role in ensuring that our computer systems comply with regulatory requirements and internal quality standards.

About Sever Pharma Solutions

Sever Pharma Solutions is a contract developer and manufacturer specializing in high-potency pharmaceuticals. The headquarters in Malmö has been developing and manufacturing pharmaceuticals for almost 50 years according to the high demands placed on pharmaceutical companies. Our customers range from large global to smaller pharmaceutical companies and we have over 340 employees in Malmö and the USA.

For more information about the company, see our website www.severpharmasolutions.com

Background

Sever Pharma Solutions has grown and expanded significantly. 10 years ago, the company had about 150 employees, today we have almost 300 employees in Malmö. We have hired a lot of staff and invested heavily in facilities and new equipment. Strong growth always means an organizational challenge. There is still a lot that we can develop and improve in our routines and processes.

Responsibilities:

• Develop and implement validation strategies for computer systems.
• Collaborate with the IT department to ensure integration and compatibility between OT and IT systems.

• Participate in projects to improve and optimize OT processes and systems.

• Perform risk assessments and gap analyses.
• Create and review validation documentation, including validation plans, test protocols, and reports.
• Qualification work for equipment and facilities.
• Stay updated with current regulatory requirements and industry standards.
• Participate in internal and external audits.

Qualifications:

• Bachelor's degree or higher in Computer Science, Engineering, or a related field.
• At least 5 years of experience in OT computer system validation within the pharmaceutical industry.
• Knowledge of network security and industrial control systems.

• In-depth knowledge of GxP regulations and FDA/EU regulatory requirements, including:
• 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• EU GMP Annex 11 (Computerized Systems)
• ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
• GAMP 5 (A Risk-Based Approach to Compliant GxP Computerized Systems)
• Experience working with OT systems, ex. LIMS, MES, and other critical production computer systems.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Ability to work independently and as part of a team.

Personal Attributes:

• Precise, thorough and detail oriented.
• Self-driven, structured and proactive.
• Flexible and adaptable.
• Positive and solution oriented.
• Good ability to prioritize tasks.

Our Values:

SEVER's values are important to us, and it is therefore important that you also share them.

Making a difference

• With the world in focus
• Scientific
• Quality

Best workplace

• Personal Development
• Respect and honesty
• Responsibility and consideration

Close to the customer

• Long-term relationships
• Create value
• Flexibility

Application:

Please submit your cv and cover letter no later than 12th of May. We will review applications continuously therefore the position can be filled before the last application date, so don’t hesitate to apply.

If you have more questions about the position, please contact Technical & Engineering: Martin Hagelthorn mhr@severpharmasolutions.com.

Union representative

Sofia Lindebring, Unionen tel. 040-641 70 87

Frida Dahlström, Akademikerföreningen tel. 040-36 18 95