Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150

Verista’s 600 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

Validation Lead (Laboratory) Analyst Responsibilities:

• Perform validation activities including generation of trace matrices and summary reports for the following instruments:

1. MTS Tensile Tester with associated computer
2. DS TOC Analyzer
3. LAL Test Equipment-Pyros Kinetix Flex Tube Reader w/software
4. Evolution Bio 260 spectrophotometer
5. Olympus CIX-100 Imaging Microscope w/ software
6. Moisture Analyzer (includes method transfer / qual)

• Generation of URS
• Review and execution of Vendor protocols
• Generation and execution of wrapper protocols (IQ, OQ, PQ) CSV and DI protocols (as needed)
• Create Requirement documents from vendor manuals
• Perform method transfers
• Independently lead the Client through the Validation Lifecycle required for their identified equipment

Requirements

• Must be willing to work in a hybrid capacity with onsite work required in Woburn, MA a large percentage of the time
• Bachelor’s degree in Engineering, Life Sciences, or a related field
• Demonstrated experience in executing laboratory instrument validation activities
• Expertise in Data Integrity
• 10+ years of role relevant experience
• Strong understanding of FDA regulations and cGMP requirements
• Capability to lead a Validation effort, from identification of applicable tests and requirements of an instrument to closure of all testing activities.
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

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

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

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.

$87,780 - $129,826

*Verista is an equal opportunity employer.