Scientist - Biotech jobs in Indianapolis, IN

Scientist - Biotech develop and conduct basic and applied research projects. Utilize advanced technologies to study biological, molecular and chemical processes. Being a Scientist - Biotech synthesize and analyze DNA, proteins and other molecules to develop new drugs, medical protocols, and products. Prepare technical papers and reports on findings. Additionally, Scientist - Biotech requires a PhD in area of specialty. Typically reports to a supervisor or manager. To be a Scientist - Biotech typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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CQV Engineer
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • 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 an experienced CQV Engineer. The engineer will play a critical role in driving project success, supporting commissioning, qualification, and validation activities, and executing IQ, OQ, PQ protocols for required equipment and systems.

    • Execute validation activities adhering to industry standards and regulations including cGMP, FDA, GAMP5, etc.
    • Draft and execute IQ, OQ, PQ protocols for required equipment and systems.
    • Perform dry runs prior to execution.
    • Collaborate with cross functional teams to ensure alignment and understanding of configuration specifications, SCADA configuration, functionality requirements, process controls, and so on.
    • Review and approve drafted documentation to ensure compliance with regulatory standards and company policies.
    • Execute computer system validation protocols.
    • Conduct risk assessment and analysis, identifying potential risks and implementing mitigation strategies.
    • Investigate deviations and implement corrective actions.
    • Support equipment, instrumentation, and calibration testing.
    • Communicate effectively with stakeholders to provide updates on validation progress, issues, and resolutions.
    • Identify and implement continuous improvement opportunities to enhance the efficiency and effectiveness of validation processes.
    • Additional responsibilities as required.


    Requirements


    • Bachelor’s degree in related engineering or scientific discipline.
    • 3-5 years of CQV engineering experience in the pharmaceutical industry. Additional computer system validation experience is a plus.
    • Extensive experience in drafting and executing validation protocols (IQ, OQ, and PQ).
    • Strong understanding of configuration specifications, SCADA configuration, object and graphical configuration, functionality requirements, and process controls.
    • Proven knowledge of automated manufacturing and processes.
    • Strong understanding and experience with critical verifications.
    • System validation experience including knowledge of PLCS, SCADA, HMIs, etc.
    • Understanding and experience with user access levels and system security is a plus.
    • Strong understanding of regulatory requirements and industry compliance standards including cGMP, GAMP5, ALCOA , etc.
    • Experienced in risk management and deviation investigation.
    • Excellent technical writing skills, with strong understanding of technical validation and system documentation.
    • Knowledge of hardware and equipment for automation lines is a plus.
    • Strong troubleshooting, analytical, and problem-solving skills.
    • Knowledge of containment principles is a plus.
    • Ability to examine and identify defects, inconsistencies, or irregularities in processes and results.
    • Strong knowledge of quality procedures and protocols.
    • Excellent communication skills both verbal and written.
    • Excellent attention to detail, time-management, and organizational skills.
    • Ability to handle multiple priorities at once and drive tight project deadlines.
    • Strong collaborative and interpersonal skills.
    • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.


    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 is committed to 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.

    #LI-JL1​

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Technical Writer/Engineer
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • 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 applica...
  • 13 Days Ago

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Senior Validation Engineer (MS&T)
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • 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 applica...
  • 13 Days Ago

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Validation Engineer (MS&T)
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • 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 applica...
  • 13 Days Ago

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Scientist
  • Eurofins USA PSS Insourcing Solutions
  • Indianapolis, IN FULL_TIME
  • Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our e...
  • 8 Days Ago

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Scientist
  • Eurofins
  • Indianapolis, IN FULL_TIME
  • Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our en...
  • 9 Days Ago

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0 Scientist - Biotech jobs found in Indianapolis, IN area

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DATA SCIENTIST
  • Defense Finance and Accounting Service
  • Indianapolis, IN
  • Summary Who may apply: United States Citizens This job is open to The public U.S. Citizens, Nationals or those who owe a...
  • 3/28/2024 12:00:00 AM

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Scientist, Biotransformation
  • Ichgcp
  • Indianapolis, IN
  • **Scientist, Biotransformation** **IQVIA Holdings Inc.** ****Indianapolis, Indiana**** Q2 Solutions is a leading clinica...
  • 3/28/2024 12:00:00 AM

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IN - IOT Data Scientist
  • HexaQuEST Global, Inc.
  • Indianapolis, IN
  • Job Description: Works with agency partners and outside stakeholders to gather and analyze data regarding a variety of i...
  • 3/28/2024 12:00:00 AM

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Sr Scientist Biotransformation
  • Ichgcp
  • Indianapolis, IN
  • **Sr Scientist Biotransformation** **IQVIA Holdings Inc.** ****Indianapolis, Indiana**** Q2 Solutions is a leading clini...
  • 3/28/2024 12:00:00 AM

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Medical Laboratory Scientist
  • Randstad Life Sciences
  • Indianapolis, IN
  • Job Description Job Description Job Details: Medical Laboratory Scientist in Indianapolis, IN 03 Months Contract 3rd Shi...
  • 3/27/2024 12:00:00 AM

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Method Transfer Scientist
  • INCOG BioPharma Services
  • Indianapolis, IN
  • Method Transfer Scientist WHO? If you’re looking to be part of something special, making a difference to society through...
  • 3/25/2024 12:00:00 AM

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Lead Data Scientist
  • Careerbuilder
  • Indianapolis, IN
  • Oracle Digital Government group is on a mission to support national governments on their digital transformation journey....
  • 3/25/2024 12:00:00 AM

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Clinical Laboratory Scientist
  • Randstad Life Sciences US
  • Indianapolis, IN
  • Job title: Medical Laboratory Scientist Address: Indianapolis, Indiana - 46219 Type: 3 months Timings: 1st Shift (7 AM -...
  • 3/24/2024 12:00:00 AM

Indianapolis is in the East North Central region of the Midwestern United States, in central Indiana. According to the U.S. Census Bureau, the Indianapolis (balance) encompasses a total area of 368.2 square miles (954 km2), of which 361.5 square miles (936 km2) is land and 6.7 square miles (17 km2) is water. The consolidated city boundaries are coterminous with Marion County, with the exception of the autonomous municipalities of Beech Grove, Lawrence, Southport, and Speedway. Indianapolis is the 16th largest city by land area in the U.S. Indianapolis is within the Tipton Till Plain, a flat to...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Scientist - Biotech jobs
$98,956 to $122,169
Indianapolis, Indiana area prices
were up 1.3% from a year ago

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