5474- Lead CQV Engineer/ Lead 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
  
  

The Cincinnati Client site is currently engaged in a major capital project. Scope includes construction of a new QC Laboratory, relocating existing lab equipment, construction of a new packaging line suite, and installation of a new packaging line.

Lead CQV Engineer/Analyst Responsibilities

Lead the team in completing the project by a set deadline

Review all validation documents to meet Pharma & Client standards. Examples are typically available. Documents may include:

• User Requirement Specifications
• Commissioning
• IQ, OQ, PQ
• Calibration
• Standard Operating Procedures
• Preventative Maintenance Plans
• Equipment will include laboratory equipment relocation, facility and utility equipment, and oral solid dose packaging line equipment
• Communicate with staff & project manager
• Monitor the progress of the documents to keep it on schedule and adjust workload to adhere to the deadline
• Serve as a point contact for the validation documents to ensure team actions remain in constructive collaboration
• Perform quality control on the Project throughout development to maintain the standards expected
• Develop and maintain weekly the project master validation tracker
• Set direction for the team priorities looking ahead to maintain schedule
• Provide updates for 3rd level schedule
• Attend project meetings, & document all issues
• Have weekly one on one sessions with the project manager regarding progress
• Input to additional staffing needs
• Define all of the required documents
• Lead all validation activity on site for the project from beginning to end
• Input to project timetables
• Set weekly direction for the team priorities by looking ahead to maintain schedule. Communicate concerns with project team
• Implement conflict management when necessary
• Perform quality checks of each team member’s work output
• Ensure that all product sample requirements are met in a timely fashion for all testing & validation
• Author and execute own documents as workload allows
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Collaborate with engineering and project teams to align validation activities with construction schedules
• Ensure all validation documentation complies with regulatory standards (FDA, cGMP)
• Validation master planning
• Conduct risk assessments and develop mitigation strategies for potential compliance issues
• Provide cross-functional support and expertise to other CQV activities as needed
  
  

Requirements

• Must be willing to work onsite in Cincinnati, OH
• Familiarity with equipment from Uhlmann, Weiler, ESS Technologies, Pharma Technologies, Antares, and Johnson Controls preferred
• Bachelor’s degree in Engineering, Life Sciences, or a related field
• 10 years of experience in CQV roles within pharmaceutical or biotech industries
• Strong understanding of FDA regulations and cGMP requirements
• Excellent documentation and communication skills
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship
  
  

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

• Verista is an equal opportunity employer.
  
  

National (US) Range

$80,426—$129,826 USD

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