Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a skilled and detail-oriented Chemist with experience in Finished Product Testing or Raw Material Analysis within the Medical Device industry. The successful candidate will play a key role in ensuring the quality and compliance of materials and products, adhering to regulatory requirements and industry standards.

• Chemist

Key Responsibilities

1. Quality Control & Analysis

• Perform chemical, physical, and instrumental testing on raw materials, in-process samples, and finished products.
• Use analytical techniques such as HPLC, GC, FTIR, UV-Vis spectroscopy, and titration to ensure material conformance to specifications.

2. Documentation & Compliance

• Accurately document all results and findings in compliance with cGMP, ISO 13485, FDA, and other regulatory standards.
• Prepare and review lab reports, Certificates of Analysis (CoA), and batch records.

3. Method Development & Validation

• Assist in developing, optimizing, and validating analytical methods for raw materials and finished products.
• Perform method transfers and support process validation activities.

4. Instrument Calibration & Maintenance

• Calibrate, maintain, and troubleshoot laboratory instruments to ensure accurate and reliable results.
• Follow established protocols for preventive maintenance and equipment qualification.

5. Collaboration & Continuous Improvement

• Work closely with R&D, Quality Assurance, and Production teams to address quality issues and support product development.
• Participate in investigations of non-conformances and implement corrective/preventive actions.
• Contribute to process improvements, cost reduction, and efficiency initiatives in the laboratory.

6. Regulatory Support

• Provide technical support during audits and regulatory inspections.
• Stay updated on industry standards, guidelines, and regulations affecting raw material and finished product testing.

Qualifications:

1. Education

• Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, or a related field.

2. Experience

• Minimum 3-5 years of experience in a Finished Product Lab or Raw Material Lab in the Medical Device, Pharmaceutical, or related industry.
• Experience with cGMP, ISO 13485, and FDA regulations.

3. Technical Skills

• Proficiency in analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistry methods.
• Strong knowledge of material characterization and quality control principles.
• Experience with Laboratory Information Management Systems (LIMS) is a plus.

4. Soft Skills

• Strong analytical and problem-solving skills.
• Excellent communication and documentation abilities.
• Ability to work both independently and as part of a team.