Verista
Validation Lead (Labs) / Lead Validation Engineer/Analyst
Verista, Woburn, Massachusetts, us, 01813
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:
MTS Tensile Tester with associated computer
DS TOC Analyzer
LAL Test Equipment-Pyros Kinetix Flex Tube Reader w/software
Evolution Bio 260 spectrophotometer
Olympus CIX-100 Imaging Microscope w/ software
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 (https://apply.workable.com/verista/)
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.
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:
MTS Tensile Tester with associated computer
DS TOC Analyzer
LAL Test Equipment-Pyros Kinetix Flex Tube Reader w/software
Evolution Bio 260 spectrophotometer
Olympus CIX-100 Imaging Microscope w/ software
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 (https://apply.workable.com/verista/)
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.