DirecciónProcess Validation Engineer
Languages : English and Spanish
Onsite / Remote : onsite required Madrid
Start : ASAP
Location : Madrid
PROJECT DESCRIPTION
Compliant execution of process, packaging and cleaning validation activities according to the Validation Master Plan for our client in Madrid site.
Including building validation strategies, writing and execution of the protocol and compilation of the final report.
Executes MS&T process projects and formulation activities providing technical support for projects associated with the currently marketed OTC products.
Support the introduction and / or transfer of products into the plant.
Work collaboratively with our client in Madrid site cross-functional team for planning and execution of the validation activities.
Personally oversee validation activities and support and train operators in the correct execution of the validation protocols.
Support Manufacturing process problem resolution, by involvement in investigations and problem solving / root cause analysis forums.
Review the impact assessments, propose corrective actions, and provide technical justifications when required.
SKILLS / QUALIFICATIONS NEEDED
7 + years of experience in validation or drug product manufacturing or related area within the pharmaceutical industry and technical knowledge is essential.
Desired Qualifications
- Broad knowledge of pharmaceutical manufacturing processes and packaging equipment / processes
- Broad knowledge and skills of cleaning validation, cleaning processes and cleaning assessments
- Strong oral and written communication skills in English
- Well organized, committed, flexible, and enjoy working on the shop floor.
- Able to work shifts when required
- Capacity to influence others without direct line authority.
- Strong leadership skills and team spirit to collaborate with varied people at different levels
- Capacity to work in autonomy while handling multiple priorities.
- Good verbal and written English
- Experience with statistical computer packages
RESPONSIBILITIES
Cleaning validation :
- Define the Cleaning validation strategy for projects where applicable.
- Perform cleaning validation for the introduction of new products to the site or changes to the current product which may potentially impact the cleaning validation status of manufacturing or packaging equipment.
- Establish cleaning assessments for the cleaning process potentially impacted by change.
- Develop the necessary documentation for the realization of the validation runs e.g. cleaning protocols & reports, new recipes and the training of these to production staff involved in the validation activity, if applicable.
- Coordinate with production to ensure that cleaning validation activity is performed.
- Coordinate with QC for the analysis of samples and reporting of results.
- In the event of non-compliance during cleaning validation, investigate, participate in impact assessment, and propose corrective actions.
- Update cleaning instructions as appropriate.
Process validation :
- Define validation strategy for the assigned projects.
- Process validation (manufacturing, storage of bulk & packaging) either for the introduction of new products / new materials to the site or changes to the current product e.
g. a change of API or excipient / change of primary packaging.
- Creation of protocols and reports to support Process Validation e.g. characterization and validation activities.
- Collaborate with Production and Quality in the creation of batch documentation required to support Process Validation e.
g. batch manufacturing records.
- Train the relevant production personnel in support of validation activities.
- Follow the production of lots of validation and realize samples.
- Manufacturing process problem resolution and support investigations into deviations during validation activities or routine production, assess and propose corrective actions.
- Follow rules of conformity defined by the guide of the good manufacturing practices of the pharmaceutical industry (cGMP) as well as the guidelines and procedures (Quality and Compliance) defined on the plant.
- Ensuring adequate documentation is available to support registration of projects.
- Assuring appropriate risk management within the validation strategy
- Assuring appropriate communication to stakeholders
- Audit readiness
