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Validation Engineer

4 months ago

Durham, United States MedPharm Ltd (formerly Tergus Pharma) Full time

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:


  1. 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
  2. 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

  1. Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product
  2. Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
  3. Collaborate with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols.
  4. Review protocols, residue limits, reports and cleaning verification and validation summary packages.
  5. Review new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program.
  6. Provide technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds.
  7. Advise on equipment improvements and/or replacements.


Equipment/Utilities Qualification

  1. Author/review URS and FRS documentation
  2. Author/review equipment qualification protocols and summary reports
  3. Author/review executed equipment qualification protocols and summary reports
  4. Assist with the execution of equipment qualification protocols.
  5. Production Oversight During Validation Events
  6. Work to ensure validation documentation becomes part of the site’s GMP documentation database
  7. 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

  1. Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
  2. Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
  3. Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
  4. Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
  5. Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches, and ideas
  6. Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
  7. Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
  8. 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