6304 - Cleaning Validation Engineer / Sr. Validation Engineer

Verista, Inc. • Devens, MA

1d • Onsite

About The Position

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
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.
Verista is an equal opportunity employer.
National (US) Range
$80,465—$122,600 USD

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.

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level