THE COMPANY:
Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.
Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
PRIMARY PURPOSE
Provide technical and process engineering support for pharmaceutical and OTC manufacturing operations throughout the product lifecycle, including process development, scale-up, technology transfer, process validation, commercial manufacturing support, equipment qualification, and continuous improvement initiatives. This position serves as a key technical resource for manufacturing operations and requires demonstrated experience operating within a cGMP-regulated pharmaceutical manufacturing environment.
MAJOR DUTIES AND RESPONSIBILITIES
- Provide day-to-day technical support for pharmaceutical and OTC manufacturing operations to ensure safe, compliant, and efficient production.
- Lead and support technical investigations related to manufacturing deviations, non-conformances, out-of-specification results, customer complaints, and process excursions. Develop scientifically sound conclusions and recommendations.
- Author and support closure of deviations, CAPAs, change controls, and technical reports in accordance with site quality systems and regulatory requirements.
- Lead or support technology transfer activities from R&D, pilot plant, or external manufacturing sites into commercial production. Conduct laboratory evaluations, engineering studies, scale-up assessments, and process risk analyses.
- Collaborate with cross-functional teams to develop manufacturing strategies and ensure the successful transfer and commercialization of new products.
- Design, optimize, and implement manufacturing processes and equipment for pharmaceutical, OTC, topical, liquid, semi-solid, and aerosol products from pilot scale through commercial production.
- Support process validation activities including protocol development, execution, data analysis, statistical evaluation, and report generation in accordance with FDA, cGMP, and company requirements.
- Author and execute equipment qualification protocols (IQ/OQ/PQ), commissioning activities, and engineering studies to support new and existing manufacturing systems
- Develop User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and technical justifications for new equipment, process improvements, and capital projects.
- Participate in equipment selection, installation, startup, and qualification activities associated with manufacturing and facility upgrades.
- Utilize Lean Manufacturing, Six Sigma, and Operational Excellence methodologies to identify and implement process improvements that improve product quality, increase throughput, reduce waste, and enhance manufacturing efficiency.
- Perform process capability analyses, trend evaluations, and statistical assessments to support data-driven decision-making and continuous improvement initiatives
- Support manufacturing readiness activities for new product introductions and process changes.
- Author, review, and revise SOPs, batch records, validation protocols, technical reports, and engineering documentation required to support cGMP manufacturing operations.
- Maintain expertise in FDA regulations, cGMP requirements, ICH guidelines, and industry best practices related to pharmaceutical manufacturing and validation.
- Support internal audits, regulatory inspections, and customer audits by providing technical expertise, documentation, and responses to observations.
- Participate in quality risk management activities utilizing tools such as FMEA, risk assessments, and control strategies.
- Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and product families.
- Make independent technical decisions within assigned projects and responsibilities that impact manufacturing performance, product quality, and regulatory compliance.
- Collaborate effectively with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, Engineering, Maintenance, Supply Chain, and Research & Development teams.
- Support capital projects from concept through implementation, including scope development, vendor interactions, commissioning, qualification, and project execution.
- Perform other duties as assigned to support business objectives and pharmaceutical manufacturing operations.
QUALIFICATIONS
Required
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or related engineering discipline.
- Minimum of 5 years of engineering experience within pharmaceutical, OTC drug, biotechnology, medical device, personal care, or other FDA-regulated manufacturing environments.
- Demonstrated experience working in a cGMP-regulated manufacturing environment
- Experience supporting process validation, equipment qualification (IQ/OQ/PQ), technology transfer, process troubleshooting, and commercial manufacturing operations.
- Working knowledge of FDA regulations, cGMP requirements, pharmaceutical quality systems, change control processes, deviation investigations, and CAPA systems.
- Strong technical writing and documentation skills.
- Ability to lift up to 40 pounds and work within a manufacturing environment.
Preferred
- 7+ years of pharmaceutical manufacturing experience
- Experience with topical drug products, semi-solids, liquids, aerosols, combination products, or other complex dosage forms.
- Experience supporting FDA inspections, regulatory audits, and customer audits.
- Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification.
- Experience with process scale-up and commercial product launch activities.
- Experience with Process Analytical Technology (PAT), statistical process control, and process monitoring systems.
- Master's degree in Chemical Engineering, Pharmaceutical Sciences, or related discipline
CRITICAL SKILLS AND ABILITIES
- Strong technical expertise in pharmaceutical manufacturing processes, process validation, technology transfer, and regulatory compliance.
- Strong understanding of FDA regulations, cGMP requirements, pharmaceutical quality systems, and validation principles.
- Demonstrated problem-solving and root cause investigation skills.
- Ability to evaluate complex technical data and translate findings into practical manufacturing solutions.
- Excellent written, verbal, and presentation communication skills.
- Strong project management and organizational skills with the ability to manage multiple priorities simultaneously.
- Ability to influence technical and operational decisions through effective collaboration and leadership.
- Strong understanding of pharmaceutical quality systems, validation principles, and quality risk management methodologies.
- Ability to work independently while maintaining strong cross-functional partnerships.
- Demonstrated attention to detail and commitment to data integrity and compliance.
- Ability to wear required personal protective equipment, including respirators, gloves, safety glasses, and other safety equipment as required.
- Ability to work flexible schedules, including evenings and weekends, when business needs require.
COMPUTER SKILLS
- Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook
- Experience with ERP, MES, electronic quality management systems (eQMS), document management systems, and statistical software preferred
- Ability to analyze and trend manufacturing data using spreadsheets, databases, and statistical tools
TECHNICAL SKILLS AND EXPERIENCE
- Experience supporting pharmaceutical process development, technology transfer, scale-up, and commercial manufacturing.
- Knowledge of process validation lifecycle concepts and equipment qualification requirements.
- Experience with root cause analysis methodologies and quality risk management tools.
- Strong data analysis and statistical evaluation skills, including Statistical Process Control (SPC).
- Experience utilizing FMEA, risk assessments, and process capability analysis.
- Familiarity with Process Analytical Technology (PAT) and continued process verification principles preferred.
- Experience supporting capital projects and equipment implementation activities preferred.
EDUCATION AND/OR TRAINING
- Bachelor's degree in Engineering required
- Master's degree preferred
PHYSICAL DEMANDS
- Must be able to lift and maneuver up to 4o pounds
- Must be capable of standing, walking, and working within manufacturing environments for extended periods
- Must be able to wear personal protective equipment, including respirators, gloves, hearing protection, and safety glasses, as required
- Must be able to access manufacturing, warehouse, and utility areas safely and effectively
