Quality Engineer II

As a Quality Engineer II at Solstice Advanced Materials, you will be an integral member of a newly established cGMP manufacturing team for our Baton Rouge, LA facility, supporting the implementation and maintenance of robust cGMP Quality Systems. This role involves the review and approval of critical documentation—including master batch records, specifications, and standard operating procedures that impact the safety, identity, strength, quality, and purity of cGMP products manufactured at the site.

You will collaborate closely with production and analytical teams to facilitate timely completion of quality system activities such as deviation investigations, CAPAs, and change controls, while also overseeing the cGMP document control system and site training program.

• Release or reject product based on detailed review of batch records and final product quality
• Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11
• Approve or reject cGMP product
• Oversee activities concerning customer complaints and/or adverse events that include performing prompt investigations, instituting corrective actions where appropriate and identifying trends
• Notify senior management of significant product quality issues and coordinate response
• Manage training matrix
• Interface with cGMP customers and regulatory agencies as necessary
• Review, approve and uphold internal and external quality agreements
• Execute cGMP document control procedures
• Conduct and host internal and external cGMP quality system audits
• Coordinate quality system improvement projects

• Bachelor’s degree in engineering or other science related discipline
• Minimum of 2 years of experience in cGMP Quality Assurance role
• Experience conducting and hosting cGMP compliance audits
• Ability to work nights and weekends as needed

• Experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant
• Familiarity with common chemical process unit operations
• Experience with managing cGMP quality processes such as deviation investigation, CAPA, change control
• Experience with design, execution and reporting of cGMP validation protocols

Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. Person, which is defined as, a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status or have the ability to obtain an export authorization.

The annual base salary range for this position is 76k-105k. Please note that this salary information serves as a general guideline. Solstice considers various factors when extending an offer, including but not limited to the scope and responsibilities of the position, the candidate's work experience, education and training, key skills, as well as market and business considerations.

In addition to a competitive salary, leading-edge work, and developing solutions side-by-side with dedicated experts in their fields, Solstice Advanced Materials employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance;
Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance;
Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and 12 Paid Holidays.

The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates.
Posting date: 2/4/2026
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Solstice Advanced Materials is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

Solstice Advanced Materials is a leading global specialty materials company that…