Quality Assurance Engineer
3 weeks ago
PSC Biotech is seeking an experienced Validation Engineer to join our team. As a key player in our quality assurance process, you will play a vital role in ensuring the safety and efficacy of our products.
About the JobThis is a second shift opportunity that requires a high level of attention to detail, excellent analytical skills, and outstanding communication abilities. You will work closely with cross-functional teams to develop and implement validation strategies, protocols, and procedures.
- Develop and execute comprehensive validation plans, including IQ, OQ, and PQ protocols, test methods, procedures, reports, and risk assessments.
- Collaborate with vendors and contractors to ensure that equipment and systems meet validation requirements and specifications.
- Provide support for regulatory inspections, conduct periodic reviews, and requalification assessments as needed.
- Ensure all required documentation is reviewed, approved, stored, and managed accurately.
- Drive continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization.
PSC Biotech is a global leader in providing essential services to the life sciences industry. Our mission is to ensure the highest standards of quality, safety, and regulatory compliance in health care product development, manufacturing, and distribution.
About YouTo succeed in this role, you should possess:
- A Bachelor's degree in a relevant engineering discipline.
- 5+ years of validation experience in the pharmaceutical manufacturing industry.
- In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
- Excellent technical writing skills, with 5+ years of experience drafting, developing, reviewing, and authorizing technical documentation.
- Strong understanding of engineering specifications (URS, DS, FS, etc.).
- Detail-oriented with a focus on accuracy and compliance.
- Ability to manage multiple priorities and prioritize tasks effectively.
- Excellent communication and interpersonal skills.
PSC Biotech offers a competitive compensation package, including a salary range of $120,000 - $150,000 per year, depending on experience. In addition to your annual salary, you will also receive:
- Medical, dental, and vision benefits, with 100% coverage for employees and 50% coverage for dependents.
- Insurance options for employee assistance programs, basic life insurance, short/long-term disability, and more.
- A 401(k) plan with company matching.
- PTO, sick time, and paid holidays.
- Education assistance.
- Pet insurance.
- Fitness benefits, including discounts and perks at qualifying gyms.
- Financial perks and discounts.
We value diversity and inclusion in the workplace and adhere to equal employment opportunity principles.
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