The Validation Engineer 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
• Oversee 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
• Pharmaceutical 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
• Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product
• Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
• Collaborate with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols.
• Review protocols, residue limits, reports and cleaning verification and validation summary packages.
• Review new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program.
• Provide technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds.
• Advise on equipment improvements and/or replacements.
Equipment/Utilities Qualification
• Author/review URS and FRS documentation
• Author/review equipment qualification protocols and summary reports
• Author/review executed equipment qualification protocols and summary reports
• Assist with the execution of equipment qualification protocols.
• Production Oversight During Validation Events
• Work to ensure validation documentation becomes part of the site’s GMP documentation database
• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
Key Competencies/Requirements
• Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
• Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
• Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
• Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
• Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas
• Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
• Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
• Interpersonal: 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
Qualifications
• Bachelor’s degree in a Technical or Life Science
• 5 – 7 years of validation experience in pharmaceutical manufacturing
• Knowledgeable in cGMPs, ISO, SUPAC, and current FDA and industry standards.