Cleaning Validation Specialist

Cleaning Validation Specialist

Location: Little Island, Cork

Working mode: Hybrid, 3 days on-site and 2 WFH

Duration: 12 months (opportunity for a contract extension)

Hours: 39 hours per week

Pay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

Imagine your next project Cleaning Validation Specialist at Johnson & Johnson Innovative Medicine. The Cleaning Validation Specialist is a member of the Technical Operations (TO) Team and a key contributor to process improvement initiatives. In addition, they should have a keen aptitude for implementing and maintaining standards and driving efficiency within the business while supporting introduction and validation of new and existing products. The Cleaning Validation Specialist provides technical support for processes by providing facilitation / technical expertise.

roles and responsibilities

Cleaning Compliance

• Responsible to ensure site cleaning practices are in line with external auditing requirements.

  Serve as the Subject Matter Expert (SME) for cleaning compliance activities on site.

• Mobilize cross-functional teams to ensure local SOPs are in line with Janssen Global and external agency requirement. Update procedure as required.

• Monitor and trend cleaning deviations and develop yearly action plans to improvement performance.

• Led the cleaning improvement projects on site, clearly displaying progress on projects in projects

• Support the investigation leads on day to day cleaning issue ensuring CAPA prevent recurring items.

• Participate or Lead the Janssen Cleaning Community of Practice, working across 4 API sites in the Janssen API network.

Investigations and Innovation:

• Collaborate with internal and external stakeholders, including Compliance Owners to support investigations /improvements, change controls, and CAPA development.

• Lead complex investigations with cross-functional teams, applying analytical and problem-solving skills to determine root causes, assess impacts, and implement process improvements.

Additional position requirements

• Required to produce high quality and accurate work in a timely manner to meet the production schedule.

• Lead and coordinate multiple projects. Prioritize and work effectively across the organization in completing them on time and in budget.

• Participate in or lead specialized task forces and teams within local Janssen Pharmaceuticals, Inc., Janssen Supply Chain and the API-Small Molecule Cluster, per policy.

• Follow all company and site policies and procedures and the intent of our Credo.

• Assume responsibility for the safety, environmental, quality, and business effects of personal work and of work performed as a team.

• Successfully complete regulatory and job training requirements

• Other projects or assignments as requested by management.

how to succeed

• PhD in Chemistry, BE/ME Chemical Engineering, Pharmaceutical Sciences, or related field.

• Minimum of 2 years of experience in a similar role within the pharmaceutical industry or equivalent.

• Previous API cleaning experience in deviation management and/or API cleaning compliance.

• Strong understanding of cGMP regulations and experience in supporting investigations and regulatory audits.

• Excellent communication and collaboration skills, with the ability to lead cross-functional teams and drive process improvement initiatives.

• Demonstrated leadership abilities, including experience in project management and team coordination.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact:  sara.marsalo@randstadsourceright.co.uk (please note that 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”.