Verista

6304 - Cleaning Validation Engineer / Sr. Validation Engineer

Verista • $80K — $122K *
Devens, MA 01434In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Chemistry, or related field
  • 5+ years of cleaning validation experience in a GMP environment
  • Experience with soil evaluation and worst-case determination
  • Familiarity with cleaning validation PQ strategy development
  • Ability to manage multiple priorities and workstreams independently

Responsibilities

  • Lead cleaning validation strategy and execution for tech transfer programs
  • Perform soil evaluation and ranking to identify worst-case products and residues
  • Define worst-case equipment trains and justification approach
  • Develop and support the PQ strategy for cleaning validation
  • Manage deviations, investigations, and CAPAs related to cleaning validation

Benefits

  • High growth potential in a fast-paced, people-focused organization
  • Competitive pay with performance-based incentives
  • Comprehensive insurance package including life, short-term, and long-term disability
  • 401(k) with employer matching
  • Tuition reimbursement and opportunities for continued education
Full Job Description
Cleaning Validation Engineer Responsibilities:
  • Lead cleaning validation strategy and execution for tech transfer programs
  • Perform soil evaluation and ranking to identify worst-case products and residues
  • Define worst-case equipment trains/circuits and justification approach
  • Develop and support PQ strategy for cleaning validation
  • Leverage existing validation data (including prior site data) to support a risk-based approach
  • Author and review validation protocols, reports, and risk assessments
  • Support cleanability and sample recovery considerations as needed
  • Coordinate and help plan/schedule validation activities across multiple workstreams
  • Manage deviations, investigations, and CAPAs related to cleaning validation
  • Collaborate cross-functionally with Manufacturing, Quality, MS&T, and Engineering
  • Ensure compliance with cGMP and regulatory expectations

Requirements:
  • Bachelor's degree in Engineering, Chemistry, or related field
  • 5+ years of cleaning validation experience in GMP environment
  • Strong experience with:
    • Soil evaluation and worst-case determination
    • Cleaning validation PQ strategy development
    • Risk-based validation approaches leveraging existing data
    • MACO calculations and acceptance limits
  • Experience supporting tech transfer or NPI programs
  • Ability to manage multiple priorities and workstreams independently

This role requires the ability to be on-site, full-time in Devens, MA.

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.

National (US) Range

$80,465-$122,600 USD

Benefits

  • 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

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

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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