7 months ago
I am currently working with a leading global biopharmaceutical organization. They focus on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. They are looking for a cleaning validation lead to join them in Dublin.
The Cleaning Validation Lead will lead and support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS). The Cleaning Validation Lead will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility and will be required to work in close collaboration with Technical Services, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful cleaning verification/validation.
Summary of Responsibilities:
- Create and maintain/update input to the Cleaning Validation Master Plan, and product specific plan to support the startup of the multi-product drug substance manufacturing facility.
- Develop and implement/update cleaning strategies for fixed and mobile parts.
- Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
- Generate and execute cleaning verification/validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
- Work closely with colleagues within the Technical Services team, and with Quality, , Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
- Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required. Utilize risk-based strategy approaches to deliver a right sized cleaning verification/validation program.
- Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
- Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required).
- Identify and implement improvements where feasible.
- Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution.
- Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations.
- Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
- Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
- Minimum 8+ years’ experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization with emphasis in Cleaning Validation.
- Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
- Lead a small team Technical team responsible for cleaning validation.
- Experience of cleaning validation is a must, and/or cleaning approaches to a multiproduct facility.
- Experience of cleaning verification/validation of Upstream/downstream processing equipment (Media prep, buffer prep, bioreactors, chromatography skids/columns, UFDF/TFF skids, Filtration skids, and process hold vessels).
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
- Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
- Ability to drive for results independently and adapt to rapidly changing priorities.
You can apply for this role by sending us your CV or by calling us now!
Specialist Validation & C&Q Recruiter
Contact: 0203 675 2956 or email firstname.lastname@example.org.
We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you.
You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.