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Formulated Solutions · 7 hours ago

Senior Commercial Process Engineer Compounding/Blending (Formulating)

Largo, FL

Full-time

Onsite

Senior Level

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention. The Senior Commercial Process Engineer is responsible for the development, continuous improvement, and technical support of manufacturing processes for pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP).

CosmeticsManufacturingPharmaceutical

H1B Sponsor Likely

Hiring Manager

Sandra Floyd

Responsibilities

Analyze commercial process monitoring data to identify trends, conduct technical investigations, and implement engineering solutions to improve yield, quality, and efficiency

Directly lead or support the transfer of new products and processes from R&D or other sites to commercial manufacturing, including conducting gap analyses and risk assessments

Author and execute validation protocols for process validation, cleaning validation, and equipment qualification. Develop and maintain essential technical documentation, including user requirements, SOPs, and reports

Investigate technical issues, lead Root Cause Analyses, and support the implementation of corrective and preventative actions (CAPAs) for deviations

Work with Quality, Manufacturing, R&D, and Project Management teams to achieve project objectives and ensure successful process implementation

Ensure all manufacturing activities adhere to regulatory requirements and GMP standards. Participate in internal and external audits and inspections

Define user requirements for new process equipment and participate in Factory/Site Acceptance Testing (FAT/SAT) and commissioning for new systems

Qualification

Chemical EngineeringGMP KnowledgeStatistical AnalysisLean Six SigmaTechnical WritingRecord KeepingCommunication SkillsProblem-SolvingCollaboration SkillsTime Management

Required

A degree in chemical engineering, biomedical engineering, or a related field

Familiarity with compounding and processing liquids, creams, ointments, emulsions and aerosols

Proficient in statistical tools (e.g., JMP, Minitab) and data analysis, with strong technical writing and presentation skills

Thorough understanding of GMP and other relevant pharmaceutical manufacturing regulations

Ability to conduct technical investigations and lead problem-solving initiatives to resolve complex manufacturing issues while operating within project completion deadlines

Strong communication, interpersonal, and collaboration skills to work effectively in cross-functional teams

Demonstrated ability for independent work, thought, and analysis

Ability to coordinate with internal groups as needed to achieve desired goals and deliverables (Manufacturing, Engineering, Supply chain, QA, QC, R&D, Project Management, etc.)

Exceptional time management and multi-tasking skills

Be able to explain technically complex theories to all levels of the organization effectively

Excellent written and verbal communication skills with expertise in good documentation practices

Ability to perform statistical analysis of data and interpretation of data

Must be capable of detailed record keeping and communicating results to others

Must be able to lift and maneuver forty pounds

Must be capable of standing for extended periods of time

Must be able to wear personal protection equipment which includes gloves and respirator when required

Ability to perform work in a manufacturing environment where there is exposure to occupational hazards

Preferred

Familiarity with Lean or Six Sigma methodologies for driving continuous improvement

Black Belt Certification a plus

Experience with pharmaceutical and consumer products related to creams, lotions, liquids, aerosols, nasal sprays, and/or gels is a plus

Cleaning validation experience is strongly preferred

Process validation experience is strongly preferred

Proficient with Microsoft Office 365, including Teams, Word, Excel, and PowerPoint

Minitab experience is preferred but not required

Lean Six Sigma Black Belt Preferred

Company

Formulated Solutions

Formulated Solutions is a contract development and manufacturing organization that focuses on solutions for pharmaceutical products.

Founded in 1999

Largo, Florida, USA

501-1000 employees

http://www.formulatedsolutions.com/

H1B Sponsorship

Formulated Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2023 (1)

2020 (1)