Regulatory Compliance Expert

4 days ago


Marquand, Missouri, United States PSC Biotech Full time
About Us

PSC Biotech is committed to providing exceptional life sciences services to clients around the world. Our team of experts works together to ensure the highest standards of quality and compliance in pharmaceutical manufacturing processes.

Job Description

We are seeking a highly skilled Validation Engineer to join our team in Indianapolis. As a critical member of our team, you will be responsible for supporting the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.

Responsibilities
  • Support the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
  • Draft, review, and deploy all required validation documentation.
  • Provide technical expertise throughout the validation lifecycle.
  • Identify potential risks and areas of improvement, and implement risk mitigation strategies.
  • Collaborate with cross-functional teams to gather requirements and align on project timelines and deliverables.
Requirements

To be considered for this role, candidates must possess a Bachelor's degree in a related engineering discipline and 2-5+ years of validation engineering experience in the pharmaceutical manufacturing industry. Strong knowledge of Kneat validation software and systems, as well as regulatory requirements and industry standards (GMP, FDA, ISO, etc.), is also essential.

Compensation

PSC Biotech offers a competitive compensation package, including a base salary of $90,000 - $110,000 per year, depending on experience and qualifications, as well as a comprehensive benefits package, including medical, dental, and vision coverage, insurance options, 401(k) matching, PTO, sick time, and paid holidays.



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