Pfizer Process Scientist / Cleaning Validation Scientist in Grange Castle, Ireland
Pfizer Grange Castle is one of the largest Biotech facilities in the world. We are seeking a Process Scientist / Cleaning Validation Scientist/Engineer to work within the Drug Substance Technical Services Team.
This is an ideal development opportunity to join a dynamic team who provide process science support to meet the ongoing requirements of the manufacturing area and support process transfer projects into the manufacturing suite. The Process Scientist / Cleaning Validation Scientist/Engineer will be part of a wider team who are responsible for providing technical support to the operating unit.
This role will mainly be focused around Cleaning Validation activities. The successful candidate will be the main point of contact within the Technical Service team for cleaning related questions and decisions. They will manage the cleaning program within a multiproduct manufacturing facility.
The successful candidate must have the ability to work on their own initiative, have a strong technical background and work independently.
The successful candidate will report into the Drug Substance Technical Services Manager.
2. Job Responsibilities:
Main point of contact in the Drug Substance Technical Services Team for all cleaning related quires.
Maintenance of the cleaning monitoring program within the manufacturing suite.
Defend the Drug Substance Cleaning Validation program during site audits.
Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
Manages projects and prepares status reports. Work with other team members to ensure cleaning projects have appropriate timelines and are correctly assessed and resources.
Develop and implement cleaning validation strategy's including grouping strategies.
Generate, execute and complete cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Drive/Support execution of cleaning validation studies including sample collection, manufacturing equipment inspections, load configuration and cycle development.
Provide expertise for trouble shooting and resolution of problems which may occur Write impact assessments in support of investigation closures or system modifications.
Review and approve all cleaning validation / monitoring documentation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site and provide leadership in the use of OE principles to optimise our technical and business processes.
Assist in training newer members of the team working on cleaning validation. Provide technical support to the operating unit ensuring that the processes are robust, appropriately validated and run so as to maintain that validated state.
Transition to support other Technical Services activities within the team to meet business demands.
• Minimum qualification of a B.Sc ./ M.Sc . or higher qualification in chemistry, biotechnology or a related discipline;
• Minimum of 2 years' experience with Cleaning Validation in the pharmaceutical / biopharmaceutical industry
• Experience in mammalian cell culture, protein purification or validation would be beneficial
Demonstrated technical capability and aptitude for technical learning.
Strong evidence of problem-solving/trouble-shooting skills.
Ability to independently plan and perform work assignments, interpret and present data.
Capability of working in a multi-disciplinary team environment.
Strong interpersonal skills with an ability to work independently across sites and teams.
Highly motivated, proactive and persistent.
Adapts to change, responds positively with a sense of urgency.
Effective communication (verbal, written).
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.