5687 - Senior CSV Analytical Instrument Engineer / Senior Validation Engineer

Verista; Summit (NJ); On-site; USD 70,000 - 114,000; Full time

Job summary

A leading company in the life sciences industry is seeking a Senior CSV Analytical Instrument Engineer in Summit, NJ. The role involves validating computerized systems and analytical instruments, ensuring compliance with industry standards, and collaborating with cross-functional teams. Candidates should possess strong problem-solving skills and a Bachelor's degree, with 4-6 years of relevant experience. The company offers a supportive culture and a range of benefits, including competitive pay and professional development opportunities.

Benefits

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Matching benefit)

Paid Time Off (Rollover Option)

Tuition Reimbursement

Team Social Activities

Qualifications

• 4 to 6 years of relevant role-specific experience.
• Experience in pharmaceutical cGxP setting.
• Direct experience with complex automated lab systems.

Responsibilities

• Conducting validation of computerized systems and analytical equipment.
• Maintaining compliant qualification and validation records.
• Designing and executing engineering studies for validation.

Skills

Problem-Solving

Critical Thinking

Attention to Detail

Education

Bachelor’s Degree

Tools

Microsoft Office

Job description

3 days ago Be among the first 25 applicants

Description

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
  
  

Senior CSV Analytical Instrument Engineer / Senior Validation Engineer Responsibilities:

Looking for a strong resource with a diverse skillset focused around Analytical Instruments accompanied by a thorough understanding of CSV principles.

• Knowledge and demonstrated experience of Computerized System and Analytical Equipment Validation
• Running test scripts and documenting results
• Experience working with IT and troubleshooting
• Experience with requirements gathering and root cause analysis activities
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed and compliant qualification and validation records
• Understanding of system design and/or configuration activities
• General understanding of capital equipment implementation and process knowledge.
• Understanding with demonstrated experience drafting and executing validation documents, such as, Val Plans, URS, IQ/OQ/PQ protocols, RTM, VSR, Deviation Management, Change Management and Project Management
• Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
  
  

Requirements

• Bachelor’s Degree or equivalent required
• 4 to 6 year of relevant role specific experience
• Proficiency using PC and Microsoft Office tools
• 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
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
• Experience in pharmaceutical cGxP setting with the ability to generate CSV/CQV deliverables
• Knowledge of 21CFR Part 11 Regulation
• Ability to work as part of a team
• Direct experience and understanding of complex automated lab and manufacturing systems
  
  

This is an on-site role in Summit, NJ

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

$70,491—$113,521 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
  
  

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

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