Senior Specialist, Commissioning, Qualification, Validation Engineering

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.  

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

BMS Cruiserath Biologics is seeking to recruit on a permanent  contract Senior Specialist, Commissioning, Qualification, Validation Engineering.

This role of CQV Engineer will be responsible for commissioning, qualification, and validation activities at BMS Cruiserath relating to GMP and non-GMP equipment/system types across multiple projects.

Commissioning involves testing systems prior to operations to confirm the correct installation and establishing that it's functioning as intended while complying with Good Engineering Practices and EHS requirements. Qualification involves testing quality-impacting equipment by verifying the necessary functionality required for the end-user and is focused on Good Manufacturing Processes through documenting IQ, OQ and PQ.

Validation processes continue throughout the lifecycle by collecting ongoing performance data to ensure the validated state remains.

Cleaning validation is a process used to provide documented evidence that equipment and facilities are properly cleaned before being used for the production of biopharmaceuticals.

Contamination can be introduced by other product ingredients, cleaning agents, micro-organisms or by other materials (e.g. air-borne particles, dust, lubricants, raw materials, intermediates).

The same equipment may be used for processing different products which may also lead to contamination, therefore adequate cleaning procedures are critical.

This position will report to the Senior Manager, Validation and will work across CQV workstreams with an initial focus on cleaning validation.

Key Duties and Responsibilities:

• Performing all aspects of cleaning sampling required for cleaning monitoring and ad-hoc cleaning verification samples.
• Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.
• Supporting product changeover activities.
• Assisting with LOTO (lockout/ Tagout) activities where required.
• Generation of standardized cleaning validation ECPs (Energy Control Plans).
• Generation of cleaning validation documentation for new product introductions, process changes, audit observations and other required actions.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
• Cleaning validation release memos to support product release.
• Oversight of the visual inspection qualification and requalification process