What are the responsibilities and job description for the Validation Specialist position at Buckeye Engineering Consultants?
Overview
This a contract position with the client with a 12 month contract that can be extended as necessary. Client is a multinational CDMO at the forefront of cutting edge innovation in the biotech space.
Join our dynamic team as a Validation Specialist and play a pivotal role in ensuring the integrity and compliance of our manufacturing processes through meticulous validation activities. In this energetic position, you will lead efforts to develop, execute, and document validation protocols that uphold the highest standards of quality assurance and quality control. Your expertise will drive continuous improvement in our quality systems, supporting the delivery of safe and effective products to our customers worldwide. If you thrive in a fast-paced environment where attention to detail and proactive problem-solving are rewarded, this is the opportunity for you!
Responsibilities
- Develop, review, and execute validation protocols for manufacturing equipment, processes, and systems to ensure compliance with industry standards and regulatory requirements.
- Conduct thorough quality audits and inspections to verify adherence to established quality management systems.
- Collect and analyze data from validation activities to identify trends, deviations, or areas for improvement in quality systems.
- Collaborate with cross-functional teams including manufacturing, quality assurance, and engineering to resolve validation issues promptly.
- Maintain detailed documentation of validation activities, including reports, deviation investigations, and change controls.
- Support ongoing training initiatives related to quality systems, validation procedures, and compliance standards.
- Participate in internal audits and support external inspections by regulatory agencies to demonstrate validation compliance.
Qualifications
- Proven experience in quality audits, quality control, or quality assurance within a manufacturing environment.
- Strong understanding of quality management principles and quality systems applicable to regulated industries.
- Demonstrated expertise in validation processes such as IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification).
- Excellent analysis skills with the ability to interpret complex data sets accurately.
- Familiarity with QA/QC procedures, manufacturing workflows, and quality inspection techniques.
- Exceptional attention to detail combined with proactive communication skills.
- Bachelor’s degree in Engineering, Life Sciences or related field; relevant certifications in Quality Management or Validation are a plus. Embark on a career that champions excellence! We’re dedicated to fostering an environment where your skills make a real impact—ensuring product safety and elevating industry standards every step of the way.
Job Type: Contract
Pay: From $60.00 per hour
Expected hours: 40 – 60 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- On-the-job training
- Paid time off
- Relocation assistance
- Vision insurance
Work Location: In person
Salary : $60