Johnson & Johnson Careers
Manufacturing Team Lead
Requisition ID: 1805685571W
ROLE: MANUFACTURING TEAM LEAD
Location: Ringaskiddy Cork, Ireland
Reports to: Senior Operations Manager
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
A Manufacturing Team Lead develops a team in the manufacture of quality biomedicines in accordance with cGMP and EHS requirements. Reporting to the Senior Operations Manager, this position is responsible for coordination, organization and scheduling of team’s activities within the Operations department. This includes management of resources and leadership of the Operations personnel to ensure that targets are met for both commercial and clinical product demand.
As a Manufacturing Team Lead, your typical day may include:
- Working assigned shift or day patterns to meet business needs and operations schedule.
- Coordination of operations team to meet production schedule in a safe, compliant and cost-effective manner.
- Completion of pulse walkdowns to ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
- Troubleshooting of process issues and escalating/collaborating with relevant support to resolve in a timely and effective manner.
- Review and approval of completed batch records.
- Support of Project and Commissioning/ Qualification activities as required
There are 3 specific areas in the manufacturing process and each area has individual responsibilities and requirements outlined below:
CELL CULTURE ACTIVITIES
- Employ strict aseptic technique to all cell culture activities.
- Monitor and control, media harvest hold area.
- Continuous monitoring of cell culture process.
- Media filtration and storage.
- Assembly and disassembly of the Bioreactor vessels.
- Assembly and disassembly of cell culture recovery equipment (ATF/Biomass systems).
- Chromatography processing of biopharmaceutical product using Unicorn/ Delta V control system.
- Filtration, Virus filtration and Ultrafiltration of purified product.
- Final filtration, filling and finishing of purified product.
BIOPROCESS SUPPLY ACTIVITIES
- Assembly and disassembly of Operations equipment for cleaning and sterilization.
- Operation of washers and autoclaves to clean and sterilize equipment.
- Operation of COP and SOP booths.
- Buffer and media preparation.
WHAT WE’RE ABOUT:
We are passionate about our work and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We endeavour to create an environment where we:
- Display passion about doing what’s right and work on own initiative.
- Become familiar with daily activities in all areas of Manufacturing.
- Facilitate an environment of continuous improvement, open communication, collaboration and teamwork to ensure that work targets for shift are met.
- Lead investigations in work area as necessary and work as a strategic partner with cross-functional teams as needed to support site goals.
- Support training of other Operations colleagues and new team members.
- Foster and environment of knowledge sharing across the team and continuous improvement procedures.
- Exposure to multiple new technologies that are shaping future biopharmaceutical industry trends.
- Work in a dynamic multi-product environment.
- Providing opportunity to work in Global cross platform initiatives and projects.
- We encourage further development through educational assistance program.
- Demonstrate values and behaviors consistent Johnson & Johnson Credo.
General Scope and Responsibilities:
- Execution of Operations activities as necessary to meet operational needs to the highest operational standards.
- Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
- Oversee all activities in compliance with corporate and cGMP/EHS regulatory requirements and ensuring any associated deviations are completed in a timely manner.
- Facilitation of root cause problem solving sessions to correct and prevent reoccurrence of issues.
- Review of documentation in compliance with site procedures and GDP.
- Ensure Operations areas are appropriately set-up to complete process steps and enforce good aseptic techniques.
- Maintenance and calibration of Operations equipment, support commissioning & qualification activities, and assist with generation, review and revision of Operations documentation.
- Developing systems to monitor quality and efficiency of area activities, and implementing continuous improvement strategies
- Ensure effective communication occurs within the team, between shift teams and with other departments
- Provide coaching and feedback to the team and individuals to aid their learning process and help them acquire the skills necessary to perform effectively both as a team and as individuals
- Provide a forum for training and ensure teams compliance with company standards
- Establishing team goals that align with the organisational goals and business/operational needs.
- Measuring these goals and ensure that specific targets are met
- Participate in regulatory audits and ensure audit readiness at all times
- Ensure effective implementation of BEX projects, Kaizen, 5S, Lean.
- Support of Commissioning and Qualification activities.
- Deputize for Operations manager as necessary.
To be part of this high performing team you will display phenomenal attention to detail, alongside:
QUALIFICATION AND EXPERIENCE:
- Third level or equivalent qualification
- Demonstration of leadership capabilities in previous roles
- Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements
- Scientific or Technical Qualification
- Supervisory/leadership experience- ideally within Operations in a Life Sciences or Biopharmaceutical environment.
- Experience within aGMP regulated environment.
MAKE A UNIQUE MARK IN YOUR CAREER
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen R&D Ireland (7566)