CSV & DI Engineer - Life Sciences (Flanders)

ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

We are currently looking for a CSV & DI Engineer at one of our clients.

The Team Leader for Computer System Validation (CSV) & Data Iintegrity (DI) has the responsibility to co-lead (in partnership with the local process owners) the effort to bring all existing CSV & DI efforts on the site in line with current industry best practices (including the dimension of risk management).

On-site presence is required for min 80%.

Main responsibilities

• Provide direction on CSV & DI best practices and corresponding science-based risk management approaches
• Oversee the various projects and corresponding resources (contractors), applying diligent project management practices and controls, to assure delivery vs plan
• Assure quality and compliance (with internal and external regulatory requirements) of projects outputs & deliverables, while closely partnering with the corresponding QA lead to assure full alignment
• Drive change management to the broader organization to assure sustainable adoption of best practices
• Mentor and coach the Local process owner (LPO) to uplift his/her knowledge to reflect industry best practices

Your profile

• Deep understanding and experience of computer system validation and data integrity in a pharma manufacturing environment
• Experience in API environment preferred with knowledge of systems like DeltaV, PI, PCS7 along with practices as effective alarm management.
• Deep understanding of both FDA and EMA requirements towards CSV and Data integrity, including hands on experience with risk-based approaches and creation of validation documents.
• Excellent project management skills, organizing, planning and coordination skills
• Strong interpersonal & communication skills
• Experience in leading teams in complex / dynamic environments
• Coaching, human change management and training skills
• Ability to navigate politics, interact at different levels of the organization, and influence without authority
• Languages; English (must), Dutch (preferred)

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group

Apply now and be a part of our amazing journey. We believe in growing together!

We are looking forward to getting to know you and your ambitions!

• Deep understanding and experience of computer system validation and data integrity in a pharma manufacturing environment
• Experience in API environment preferred with knowledge of systems like DeltaV, PI, PCS7 along with practices as effective alarm management.
• Deep understanding of both FDA and EMA requirements towards CSV and Data integrity, including hands on experience with risk-based approaches and creation of validation documents.
• Excellent project management skills, organizing, planning and coordination skills
• Strong interpersonal & communication skills
• Experience in leading teams in complex / dynamic environments
• Coaching, human change management and training skills
• Ability to navigate politics, interact at different levels of the organization, and influence without authority
• Languages; English (must), Dutch (preferred)

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group

Apply now and be a part of our amazing journey. We believe in growing together!

We are looking forward to getting to know you and your ambitions!

ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

We are currently looking for a CSV & DI Engineer at one of our clients.