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Live In Fda Scientist Jobs in Indiana (NOW HIRING)

PSC Biotech

CQV Engineer

Indianapolis, IN · On-site

$60K - $65K/yr

Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP ... Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences. * 1-3 ...

PSC Biotech

CQV Engineer

Indianapolis, IN · On-site

Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP ... Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences. * 1-3 ...

PSC Biotech

CQV Engineer

Indianapolis, IN · On-site

Strong knowledge of equipment and process validation in FDA-regulated environments. Familiarity ... live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying ...

INCOG BioPharma Services

Senior IQC Scientist

Fishers, IN · On-site

$82K - $112K/yr

The IQC Sr Scientist - Physical Testing is responsible for generating ALCOA+ data, upholding INCOG ... Experience participating in and/or hosting FDA, EMA, or client GMP audits/inspections. * Experience ...

INCOG BioPharma Services

Senior IQC Scientist

Fishers, IN · On-site

$85K - $117K/yr

The IQC Sr Scientist - Physical Testing is responsible for generating ALCOA+ data, upholding INCOG ... Experience participating in and/or hosting FDA, EMA, or client GMP audits/inspections. * Experience ...

INCOG BioPharma Services

Senior IQC Scientist

Fishers, IN · On-site

$82K - $112K/yr

The IQC Sr Scientist - Physical Testing is responsible for generating ALCOA+ data, upholding INCOG ... Experience participating in and/or hosting FDA, EMA, or client GMP audits/inspections. * Experience ...

INCOG

Senior IQC Scientist

Fishers, IN · On-site

$85K - $117K/yr

The IQC Sr Scientist - Physical Testing is responsible for generating ALCOA+ data, upholding INCOG ... Experience participating in and/or hosting FDA, EMA, or client GMP audits/inspections. * Experience ...

Lilly

Clinical Research Scientist

Indianapolis, IN · On-site

... are conducted in compliance with applicable regulations, laws, guidance (e.g., FDA, ICH), Good ... Provide expert scientific and clinical support to U.S. business activities across rheumatology.

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All JobsLive In Fda Scientist JobsLive In Fda Scientist Jobs in Indiana

Live In Fda Scientist information

What is the difference between Live In Fda Scientist vs Fda Reviewer?

AspectLive In Fda ScientistFda Reviewer
Required credentialsBachelor's or Master's in Life Sciences, relevant experienceSimilar credentials, often with advanced degrees
Work environmentOn-site, often in government or research facilitiesOffice-based, reviewing submissions at FDA headquarters or regional offices
Employer and industry usageFederal government, regulatory scienceFederal government, regulatory review
Common search intentJob duties, qualifications, work conditionsComparison of roles, responsibilities, career path

The Live In Fda Scientist and Fda Reviewer roles both require scientific expertise and federal employment credentials. While the Live In Fda Scientist often involves conducting research and scientific analysis on-site, the Fda Reviewer primarily focuses on evaluating regulatory submissions and documentation. Both roles are integral to FDA operations, but they differ in daily tasks and work environment, with the scientist more research-oriented and the reviewer more review-focused.

Is it hard to get hired by the FDA?

Getting hired as a Live In FDA Scientist can be competitive due to strict qualification requirements, including relevant education, experience, and certifications such as a background in regulatory science or laboratory work. The hiring process often involves multiple interviews, background checks, and demonstrating expertise in areas like compliance, data analysis, and scientific research.

What are the key skills and qualifications needed to thrive as a Live-In FDA Scientist, and why are they important?

To thrive as an FDA Scientist, you need a strong background in life sciences or chemistry, typically with an advanced degree (MS or PhD) and experience in research or regulatory affairs. Familiarity with laboratory instrumentation, data analysis software, and FDA regulatory systems is essential, and certifications like RAC (Regulatory Affairs Certification) can be advantageous. Attention to detail, critical thinking, and excellent communication skills help you interpret data accurately and collaborate effectively with multidisciplinary teams. These skills ensure scientific integrity, regulatory compliance, and the advancement of public health through safe and effective products.

What is a Live In FDA Scientist?

A Live In FDA Scientist typically refers to a regulatory scientist who works for the U.S. Food and Drug Administration (FDA) and may be involved in on-site or continuous monitoring of studies, often in clinical or laboratory settings. Their role includes evaluating scientific data, ensuring compliance with federal regulations, and overseeing the safety and efficacy of products such as drugs, biologics, or medical devices. Live-in positions might be required for research facilities needing 24/7 oversight, although such roles are rare and specialized. These scientists play a crucial role in public health by supporting the FDA’s mission to protect consumers.

What are some unique challenges faced by a Live-In FDA Scientist, and how can they be managed?

A Live-In FDA Scientist often works in environments such as research facilities or clinical trial sites where on-site presence is essential. This setup can present challenges like maintaining work-life balance, adapting to extended hours, and managing confidentiality due to the sensitive nature of ongoing research. Successful candidates typically develop strong time management skills, set clear personal boundaries, and foster open communication with team members to ensure both professional responsibilities and personal well-being are balanced. Collaboration with multidisciplinary teams is frequent, and adaptability is key to thriving in this dynamic role.
What are the most commonly searched types of Fda Scientist jobs in Indiana? The most popular types of Fda Scientist jobs in Indiana are:
What cities in Indiana are hiring for Live In Fda Scientist jobs? Cities in Indiana with the most Live In Fda Scientist job openings:
Live In Fda Scientist jobs near you
CQV Engineer

CQV Engineer

PSC Biotech

Indianapolis, IN • On-site

$60K - $65K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are hiring a motivated CQV Engineer responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.
  • Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
  • Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
  • Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
  • Troubleshoot and resolve issues related to equipment and process performance.
  • Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
  • Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
  • Additional responsibilities as required to drive successful validation project deliverables.

Requirements
  • Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences.
  • 1-3 years of validation experience within the pharmaceutical, biotech, or medical device industries.
  • Strong knowledge of equipment and process validation in FDA-regulated environments.
  • Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.
  • Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities.
  • Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication abilities.
  • Strong time management and organizational skills.
  • Detail-oriented mindset with a commitment to maintaining high-quality standards.
  • Must be authorized to work in the US.
  • No C2C at this time.

Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • 401(k) and 401(k) matching
  • PTO, Sick Time, and Paid Holidays
  • Education Assistance
  • Pet Insurance
  • Discounted rate at Anytime Fitness
  • Financial Perks and Discounts
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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