Validation Specialist

Validation Specialist (Regulatory)

Location: Schaffhausen  

Duration: 12 months contract (hybrid/remote options)

Hours: 40h

Required : English mandatory, German desirable, Scientist, Process Validation or Qualification, ICH guidelines

About the department: 

At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s most significant healthcare challenges. Our Corporate, Pharmaceutical, and MedTech teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare?

The Role:

This role is for a Process Validation Scientist role in aseptic DP manufacturing. The main responsibility is to map out the tech transfer (manufacturing process and equipment) strategy of late-stage biologics/large-molecules DPs to the parenteral manufacturing site. The DP manufacturing process mainly consists of aseptic compounding and filling in vials and pre-filled syringes. In this role the key responsibilities include technical support for the strategy and execution of Technology Transfers and Process Performance Qualification (process validation) of large molecule programs.

This person will provide the regulatory insight and support the DP leads to effectively deliver qualification of equipment, aseptic process simulation, processing/hold times, and manufacturing processes in line with the supply chain network strategy and in compliance with the regulatory framework. 

This role will partner with the Analytical, Process, Quality, and Regulatory technical leads to ensure DP manufacturing equipment and processes are flawlessly introduced into the supply chain network and ongoing production consistently satisfies quality and regulatory requirements.

Key Competencies:

Work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in-depth evaluation of factors in multifunctional areas.

Collaborate and influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.

Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during qualification of equipment.

The incumbent should have expertise in ICH quality guidelines and late-stage biologic DP manufacturing. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.

Main Responsibilities:

• Support complex technology transfers with a focus on right-first-time execution and risk management.

• Translate late-stage regulatory DP manufacturing strategy into tech transfer plan

• Author, review, and approval of technical and regulatory documents (e.g., batch records, validation protocols, control strategy, and reports).

• Support DP Process Performance Qualification and preparation of regulatory reports.

• Support the internal and external teams in qualification of DP manufacturing equipment.

• Perform as SME to identify technical areas for improvement, and supply chain improvement.

• As needed, provide SME input on change management, product impact assessment and implementation of changes to the DP manufacturing processes.

• Influences others to accept new ideas, approaches or concepts or gains alignment on divergent issues.

The ideal candidate for this position should have:

• Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals or bachelor’s degree + 8 years of experience.

• Works in an international environment across different time zones

• Domestic travel: ~25% of time based on role and specific business goals.

• Virtual Network interactions, utilizing available infrastructure to communicate with key partners and stakeholders

Proven track record in in at least three of these areas:

• DP comparability

• Equipment qualification

• Pharmaceutical process development

• Technology transfer

• Process validation

• Demonstrated technical competency and experience with biologic DPs.

• Demonstrated experience in technology transfers projects.

• Partnering with R&D and commercial supply to improve the fit for plant and commercialization of new products into the supply chain.

• Personal and interpersonal skills / Leadership skills

• Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.

• Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.

• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.

• Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.

• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.

• Ability to manage complexity and change.

• Motivated, self-starter able to work independently with demonstrated problem solving skills.

• Drives for innovation and change to ensure competitiveness.

• Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.

benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson .https://www.jnj.com/

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.

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”.