As Validation Engineer you will provide direct validation support to pharmaceutical development and manufacturing operations. This role performs validation activities accurately and completes documentation fully and compliantly.
Key Responsibility Areas:
- Site Master Validation Program: Provide input and administration of the site master validation program as well as assist in maintaining the site validation master plan while following validation policies; maintain validation life cycle approach for site
- Validation: Author/Execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification
Specific Responsibilities
Responsibilities include, but are not limited to:
Cleaning Validation
- with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product
- provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
- with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols.
- protocols, residue limits, reports and cleaning verification and validation summary packages.
- new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program.
- technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds.
- on equipment improvements and/or replacements.
Equipment/Utilities Qualification
- URS and FRS documentation
- equipment qualification protocols and summary reports
- executed equipment qualification protocols and summary reports
- with the execution of equipment qualification protocols.
- Oversight During Validation Events
- to ensure validation documentation becomes part of the site’s GMP documentation database
- to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
Key Competencies/Requirements
- Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
- Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
- Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
- Find opportunities to improve and extend their contribution to the organization and their teammates
- Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches, and ideas
- Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
- to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
- Develop and maintain effective relationships with others; relate well to people from varied backgrounds and in different situations; show understanding, courtesy, tact, empathy, concern, and politeness