6304 - Cleaning Validation Engineer / Sr. Validation Engineer
About this role
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
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.
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
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