Validation Engineer
1 week ago
PSC Biotech is a leading provider of essential services to the life sciences industry, ensuring that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Job SummaryWe are seeking an experienced Validation Engineer to join our team in Indianapolis. The successful candidate will have a strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and validation principles.
Key Responsibilities- Lead the development and execution of commissioning, qualification, and validation protocols for a range of equipment and systems.
- Draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
- Provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
- Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
- Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
- Collaborate with cross-functional teams to gather requirements and align on project timelines and deliverables.
- Contribute to the continuous improvement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements at all times.
- Bachelor's degree in a related engineering discipline.
- 3-5 years of validation engineering experience in the pharmaceutical manufacturing industry.
- In-depth knowledge of regulatory requirements and industry standards (GMP, FDA, ISO, etc.).
- Strong understanding of pharmaceutical manufacturing processes and equipment.
- Experience with risk-based validation approaches.
- Excellent analytical, problem-solving, and technical writing skills.
- Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Medical, dental, and vision insurance, with PSC Biotech paying 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.
- Fitness benefits, including membership discounts and other perks/services at qualifying gyms.
- Financial perks and discounts.
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