Manufacturing Process Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Manufacturing Process Specialist to join our contingent workforce on a growing team in Janssen Pharmaceuticals in Cork for an initial 12 month contract. 

About Janssen Pharmaceuticals:

Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services.  Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.  

We are expanding our site to allow us to meet the critical needs of patients around the world.  The expansion plans involve an investment of more than €300 million that will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.

The Role:  

The Manufacturing Process Specialist (IPT) is a member of the operations dept., playing a key role in the planning of analytical instrumentation validation and equipment lifecycle management including the management of vendor relationships. Input into all aspects of analytical instrument lifecycle through commissioning and qualification, including on-going sustaining operations of the facility. All instrumentation validation activities are conducted in conjunction with Automation systems, in accordance with Janssen Sciences guidance on the qualification of analytical instrument and computer systems. 

Key Responsibilities:

• Conduct validation activities in compliance with US and EU regulations, Janssen procedures and EHS requirements.
• Participate in the procurement equipment to ensure that they comply with CGMP requirements.
• Develop validation documentation as required (e.g. protocols, procedures, reports).
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• Review and approve documents prepared by other departments and contractor organizations (e.g. calibration plans, vendor SLA, vendor IOPQ, method statements, change controls).
• Execute qualification protocols as required.
• Prepare reports of executed protocols for review by QA.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions during qualification activities.
• Prioritize qualification activities in line with the departmental priorities.
• Co-ordinate qualification activities with vendor and automation/ execution systems.
• Review, Approval and Completion of ClearQuest activities
• Co-ordinate qualification document review and approval.
• Collate and organize qualification files for turnover to QADC.
• Attend identified training, required to fulfill the role of Manufacturing Process Specialist (IPT).
• Act a SPOC for instrumentation issues
• Assist in the development of training material for use of equipment
• Participate in cross-functional teams as required.
• Support in the context of an SME of deviations (including customer complaints, EHS incidents, quality investigations etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions
• Completion of User Audits, Periodic Audit Trail reviews, Periodic validation status audit
• Adds new users to the systems and assigns privileges
• Sets up review and approval routings for SOPs and other GMP regulated documents
• Participates in upgrade activities of the system as appropriate.
• Generates reports from the system as directed
• Domestic and international travel may be required.
• Issuance of safety permits

Candidate Requirements:

• A Bachelor's Degree or similar qualification in mechanical or industrial engineering
• The person will have a proven track record in the Qualification of analytical instruments
• Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
• Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries.
• Ability to apply CGMP regulations and guidelines to all aspects of qualification activities

If you meet our requirements and are interested in hearing more about our Manufacturing Process Specialist, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!