5920- CQV Engineer - Validation Engineer

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues


• We commit to client success at every turn


• We have the courage to do the right thing


• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.


• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

CQV Engineer Responsibilities:

• Operating Spray Dryer equipment for 3 campaigns of batches
  o Cleaning and Changeover of Equipment
  o Material Weigh Out
  o Operate during spray drying
  o Execute Master Batch Record and other GMP documentation using Good Documentation Practices
  o Aliquoting samples
  o Perform initial troubleshooting of process equipment in the event of an issue


• Technical Writing:
  o Change Control
  o Deviation writeup and investigation
  o Support determination of root cause and CAPAs

Requirements:

• Onsite work requirements in Durham, NC


• 40 hour weeks with potential for longer days and/or off shift work


• Physical requirements:
  
  
  
  • Must be able to lift 25 lbs
  
  
  • Will be assembling cleaning/manufacturing equipment
  
  
  
  


• Must be eager to learn


• Critical thinking skills required to perform and improve the spray drying process


• Complete onsite training in Spray Dryer operation to facilitate deep understanding of the Batch process and Master Batch Record


• Demonstrated experience in a GMP regulated environment (1-3 years)


• Strong technical writing skills


• Previous experience with CAPA, root cause analysis and Deviation Investigation highly preferred

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com