Manufacturing Process Specialist

Manufacturing Process Specialist (Upstream OR Downstream)

Location: Leiden, Netherlands

Duration: 9 months 

Hours: 40 hours per week

Imagine your next project as a Manufacturing Process Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

General Activities:

• Materials planning and ordering for USP or DSP operations

• Preparation, review, and updates of GMP documentation (MBRs, SOPs, WIs)

• Act as Change Control Assessor and perform implementation activities

• Monitor and troubleshoot process and equipment issues (bioreactors or purification systems)

• Serve as business system owner or subject matter expert (SME)

• Support batch readiness and release documentation

• Coordinate or release clinical manufacturing batches as required

• Represent Operations on cross-functional project teams

• Monitor and report process performance using statistical tools

• Participate in or lead investigations and resolve non-conformances (NCs)

• Engage in or lead cross-functional project teams

• Support commissioning, qualification, and validation activities

• Provide process and equipment training within Manufacturing

• Support ongoing studies from Validation, OTS, and other supporting departments

General Scope of Responsibilities:

• Lead by example and maintain high standards of performance and GMP compliance

• Generate and review manufacturing documentation as required

• Prioritize and schedule tasks in alignment with the Master Production Schedule

• Ensure all activities comply with cGMP and EHS regulations

• Complete documentation following site procedures and Good Documentation Practice (GDocP)

• Support execution of operational tasks and business-driven needs

• Actively contribute to equipment and process commissioning and qualification

• Provide training and guidance to team members

• Support a culture of continuous improvement

• Perform tasks delegated by the Manufacturing Lead in line with procedures and company values

Leadership Responsibilities / Individual Contribution:

• Report to the Manufacturing Lead

• Represent Operations in cross-functional projects

• Be familiar with daily activities in either USP or DSP manufacturing

• Promote open communication and a continuous improvement mindset

• Lead or support investigations and improvement initiatives

• Mentor and support training of colleagues

• Show initiative and share ideas for process or system enhancements

• Uphold company Credo values, especially integrity

how to succeed

Essential:

• PDEng graduate, or a Master’s degree AND 3 years’ experience, or Bachelor’s AND 5 years’ experience in Biochemistry, Biotechnology, Pharmacy, Engineering, or related fields

• GMP Compliance Experience

Desirable:

• Experience in either upstream (cell culture/bioreactors) or downstream (purification/chromatography) manufacturing in a GMP-regulated environment

• Knowledge of AKTA, UFDF, POD systems, or bioreactor operations

• Exposure to process engineering, troubleshooting, and root cause analysis

• Experience with commissioning and qualification of new equipment

• Proficient in Microsoft Word, Excel, Outlook

• Familiarity with project management methodologies (e.g., FPX)

• Adaptable and flexible

• Strong interpersonal and communication skills

• Detail-oriented and organized

• Proactive and performance-driven

• Collaborative and team-focused

• Innovative with a continuous improvement mindset

details

• This role offers a very competitive hourly rate. 

• This contract will run for a 9 month period initially. 

• This is a hybrid position (3 days on-site)

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.