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Johnson & Johnson

Makes prescription drugs and medical devices

Manufacturing Process Specialist

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeLoughbeg, Ringaskiddy, Co. Cork, IrelandIn-person

About the Job

Requirements

  • A bachelor's degree in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
  • Manufacturing experience in a GMP-regulated environment.
  • Experience with cell culture or purification processes.
  • Project or new equipment installation experience.
  • Process engineering experience.

Responsibilities

  • Represent Operations on cross-functional project implementation teams.
  • Monitor and troubleshoot manufacturing processes and equipment issues, and optimize processes.
  • Monitor and report process performance using statistical process control.
  • Troubleshoot DCS and PLC control systems.
  • Investigate and resolve issues raised within the Manufacturing Department.
  • Participate in or lead cross-functional teams when required.
  • Support commissioning and qualification activities.
  • Prepare and update batch records, procedures, and work instructions.
  • Provide process- and equipment-related training within the Manufacturing Department as required.
  • Complete assigned tasks supporting the manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
  • Assure the safe accomplishment of job activities and follow good environmental practices and procedures.
  • Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
  • Carry out activities in compliance with corporate and cGMP/EHS regulatory requirements and site procedures.
  • Complete documentation in compliance with site procedures and GDP.
  • Execute activities as needed to meet operational and business needs.
  • Lead, support, and participate in commissioning and qualification activities for current and future projects, including annual requalification activities, and support validation activities.
  • Prioritize and schedule activities to support business needs and the Master Production Schedule.
  • Lead and support investigations and resolution of plant problems.
  • Generate, assist with generating, review, and revise Manufacturing documentation as necessary.
  • Complete personal training requirements in compliance with site procedures and train and support new Manufacturing group recruits.
  • Support ongoing studies conducted by Validation, OTS, and other support functions.
  • Report to the Operations Manager and represent Operations on cross-functional project teams.
  • Be familiar with daily Manufacturing activities and facilitate continuous improvement and open communication.
  • Lead investigations in the work area and cross-functional teams as necessary to support site goals.
  • Support training of Manufacturing colleagues.
  • Share ideas and suggestions for improvement and encourage others to do the same.
  • Interface with site departments, Operations, Maintenance, Engineering, Quality, Logistics, OTS, Validation, Training, and other Janssen Biologics sites, including at Team Leader, Manager, and Director levels.
  • Consider the internal customers of the Manufacturing Department and their requirements.
  • Comply with the company EHS Policy, Safety Statement, associated EHS procedures, local legislation, and duties in the site EHS Manual.
  • Take reasonable care to protect personal safety and the safety of colleagues affected by one's actions.
  • Understand the potential EHS impact of work activities, attend required EHS training, use required PPE and safety equipment, and report incidents, accidents, and near misses.

Desired Qualifications

  • Commissioning and qualification experience.
  • Experience with Microsoft Word, Excel, and Outlook.
  • Experience with DCS (such as Delta V), SCADA, and PLC systems.
  • Experience with SAP, LIMS, or other business systems.
  • Training in Six Sigma, Kepner-Tregoe, or a similar problem-solving or decision-making methodology.
  • Ability to work as part of a team with attention to detail.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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