Process Investigator

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Learn more at for a Process Investigator function in the Manufacturing Science & Technology (MSAT) CAR-T EMEA organization located in Ghent Belgium.

The MSATCAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation process system engineering data architecture and continuous process verification and process investigation.

The Process Investigator is the role for providing quality investigation insights over the manufacturing of a personalized cell therapy to support both clinical and commercial requirements in a sterile GxP environment. This includes assessing process information reviewing in-the-field manufacturing investigations follow up on various departmental post-implementation optimizations and tracking of quality metrics while ensuring high quality and compliant product supply.

The Process Investigator will be part of this MSAT team and is responsible for:

• Own the investigation process and methodologies create awareness and educate the organization on the importance of and how to adequately and efficiently handle and document quality non-conformances.

• Responsible for handling multiple department manufacturing investigations as appropriate to meet critical release windows (the highest priority being safe compliant and timely product release for the patient).

• Build solid and long-lasting connections with different stakeholders in order to ensure smooth alignment and handling of complex investigations while acting as the shopfloor single point of contact.

• Collaborate with functional departments to provide guidance and determine resolution for manufacturing issues/deviations/non-conformances.

• Apply and implement appropriate risk assessment methodologies and root cause analysis tools and assess product quality impact.

• Perform analysis on quality indicating data and identifying trends. Ability to identify/remediate gaps in processes or systems with correct follow up by effectiveness checks.

• Ensure connection between recurrent deviations and process robustness activities perform trending and feed the organization based on lessons learned from investigations.

• Draft feed review/revise and/or support writing of (not limited to): Investigations (incl. impact and risk assessments corrections CAPAs) Reports Qualification and validation protocols and reports Technical assessments and rationales SOPs and work instructions.

• Perform tasks in a manner consistent with the safety policies quality systems and cGMP requirements.

• Require minimal direction to complete tasks knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.

• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.

• Drive continuous quality improvements. Support the implementation of quality investigation resulting CAPAs related to the manufacturing process together with MSAT process expert process engineer and knowledge management.

• Ensure seamless flow of knowledge and information across functions departments and with other sites when applicable resulting in fast and effective resolution of issues.

• Act as delegate for Investigation Lead responsibilities upon request.

• Continuously maintain compliance with internal training requirements.

• Stay up to date with regulatory requirements and state of the art guidelines maintain permanent inspection readiness actively support regulatory inspections and preparation thereof as SME and support the implementation of actions resulting from such inspections.

Qualifications & Requirements:

• A Bachelors degree in Molecular Biology Cell Biology Biochemistry or related area in the Life Sciences is required. A Masters Degree in the aforementioned or related fields is preferrable.

• Experience in an industrial manufacturing or regulated environment is required

• Fluent in English.

Capabilities knowledge and skills:

• Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.

• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to cell based product manufacturing or cell processing.

• Ability to work independently and successfully under minimal supervision and integrate cross-functional issues and balance competing priorities effectively.

• Born team player.

• Excellent scientific writing skills.

• Being able to manage shifting priorities and multiple tasks simultaneously to meet critical deadlines in a fast paced and dynamic growing environment.

• Positive and pro-active attitude.

• Results driven while working within GxP framework of procedures and rules.

• Excellent organizational skills.

• Strong analytical mind problem solving and critical thinking skills. Being able to trouble shoot and resolve complex scientific/technical problems.

• Advanced computer skills and practical knowledge.

• Clear communicator with ability to build strong partnerships.

• Accurate Authentic Transparent Passionate Fearless and Accountable.

• The individual will communicate effectively with people at all levels including the ability to understand their priorities and to earn their respect and trust along with the willingness to provide them with the best

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: