6541 - Lab Technician / Validation Engineer New Indianapolis, IN

Verista; Indianapolis, Northern (IN, KY); Hybrid; USD 69,000 - 95,000; Full time

Benefits offered by this job

Competitive pay

Performance-based incentives

Company-paid Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

Health Savings Account

Paid Time Off

Holidays

Sick Time

Tuition Reimbursement

Team Social Activities

Employee Recognition

Employee Referral Program

Paid Parental Leave

Bereavement

Job summary

Verista is seeking a Lab Technician / Validation Engineer in Indianapolis, IN. The role focuses on QC laboratory operations, equipment qualification testing (IQ/OQ/PQ), and collaboration with cross-functional teams to support batch release and product testing.

Ideal candidates have 3–5 years in regulated environments, strong problem-solving abilities, and proficiency with Microsoft Office, Outlook, and Windows.

Qualifications

• 3-5 years of regulated industry experience with knowledge of quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485).
• Strong problem solving and analytical thinking skills.
• Excellent verbal and written communication in English.

Skills

Problem solving

Communication (English)

Self-management

Teamwork

Curiosity

Critical thinking

Tools

Microsoft Office Suite

Outlook

Windows

Job description

6541 - Lab Technician / Validation Engineer

Indianapolis, IN

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
• Develop and maintain knowledge of applicable regulations and requirements.
• Provide Quality Control (QC) support for the QC laboratory.
• Implement, maintain, and /or enhance appropriate quality systems within QC laboratory.
• Author, maintain, and instruct on on-the-job courses for laboratory equipment, testing inspection, and laboratory operations.
• Perform and oversee QC laboratory equipment setup, operation, and maintenance.
• Build and maintain working relationships with multiple functions and Contract Manufacturers supporting batch release testing
• Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing.
• Participate in departmental process improvement activities.
• Maintain laboratory inventory management.
• Assist in equipment qualification testing activities including IQ, OQ, and PQ.
• Maintain and manage the reference sample retention area.
• Support and perform laboratory device testing for commercial and development product using good documentation practices.
• Perform test equipment setup, operation, and maintenance.
• Support shipping and receiving activities as assigned.
• Create /Edit lot release workshops as needed.
• Maintain laboratory notebooks, including authoring, revision, and retirement
• Participate in regulatory agency and internal inspections.
• Ensure that all test equipment is properly validated and maintained for its intended use.
• Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate.
• Support Change Management through roles of originator and /or executor of tasks and implementation steps.

Requirements:

• Minimum of 3-5 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e .g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL )
• Strong problem solving and analytical thinking skills
• Strong verbal and written communication skills in English.
• Self-management / motivated.
• Demonstrated techComputer literate in Outlook, Windows and Microsoft applications
• Excellent teamwork and abilitiy to multi-task.
• Strong curiosity skills with the ability to question /identify issues and work to resolution.
• Strong critical thinking /problem solving skills with an ability to apply rationale.

Additional Preferences:

• Three years experience in Quality or TS /MS support.
• Experience with Microsoft Office Suite
• Above average computer literacy and computer skills – specific training relating to software used will be provided.
• Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems.
• Ability to mentor /train others – share learning.

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

$69,300 - $95,358 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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

As set forth in Verista, Inc.’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.