Process Engineer

1) SUMMARY / OBJECTIVE

Seeking a highly technical and hands‑on Process Engineer to support cosmetic and OTC manufacturing operations in a fast‑paced contract manufacturing environment. This role will be responsible for:

• Scaling new formulations from laboratory development into efficient commercial production.
• Troubleshooting and reprocessing out-of-specification (OOS) batches.
• Owning and driving continuous improvement initiatives, as well as optimizing manufacturing processes for quality, efficiency, and throughput.

2) ESSENTIAL FUNCTIONS

The individual must be able to perform each essential function satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform these functions.

Scale Up & Commercialization

• Lead scale‑up activities for new cosmetic, personal care, and OTC formulations from bench and pilot scale and to full scale commercial manufacturing.
• Translate laboratory processes into robust and repeatable manufacturing instructions and batch procedures.
• Evaluate processing parameters including mixing speed, shear requirements, temperature profiles, order of addition, homogenization, transfer rates, filtration, cooling curves, and hold times.
• Support pilot and validation batches to ensure successful commercialization and manufacturability.
• Partner with Innovation Chemists during formula development to proactively identify scale‑up risks and manufacturing limitations.
• Generate and maintain process protocols, manufacturing procedures, process flow diagrams, scale‑up and validation reports.
• Collaborate with Compounding and Scheduling teams to support first production execution and troubleshooting.
• Support new Technology Transfer initiatives for prospective customers.

OOS Batch Troubleshooting & Reprocessing

• Investigate and perform root cause analysis and statistical trending on manufacturing deviations, process failures, and out‑of‑specification batches.
• Evaluate viscosity adjustments, pH corrections, fragrance incorporation issues, phase separation, aeration, precipitation, color variation, and stability‑related concerns.
• Develop technically sound reprocessing strategies to recover batches back into specification while maintaining product quality and regulatory compliance.
• Partner with Quality and Regulatory teams to assess rework feasibility and compliance implications.
• Provide technical support when experiencing compounding issues and assist with real‑time compounding troubleshooting support.
• Assist in retraining Compounding leadership on new techniques and processes to resolve relevant compounding issues.

Continuous Improvement & Process Optimization

• Drive continuous improvement initiatives focused on throughput, cycle time reduction, yield improvement, scrap reduction, downtime reduction, and process robustness.
• Analyze manufacturing trends and process data to identify optimization opportunities.
• Improve process capability and batch‑to‑batch consistency through standardized operating parameters.
• Support Lean Manufacturing and Operational Excellence initiatives.
• Conduct DOE (Design of Experiments) and process capability studies where applicable.
• Optimize existing manufacturing processes for mixing efficiency, heating/cooling performance, filtration, transfer operations and bulk storage capabilities.
• Support implementation of new equipment, process technologies, and automation improvements.

Cross-Functional Responsibilities

• Act as technical liaison between R&D Innovation, Compounding, Quality, Engineering, Procurement, and Customer teams.
• Support customer technical discussions related to manufacturing feasibility and process capabilities.
• Assist with investigations related to customer complaints, nonconformances, and stability concerns.
• Support technology transfer activities between sites.
• Participate in Stage Gate, commercialization, and process review meetings.

3) COMPETENCIES

• Strong formulation processing knowledge, excellent root cause investigation skills, and practical experience with liquid, emulsion, surfactant, alcohol, and OTC manufacturing systems.
• Strong understanding of fluid dynamics, heat transfer, mixing technology, emulsification, rheology, and process controls.
• Knowledge of GMP manufacturing requirements for cosmetics and OTC products.
• Familiarity with CAPA, change control, deviation management, and validation activities.
• Proficiency with data analysis and process trending tools. Lean Six Sigma certification is a plus.

• High attention to detail with strong documentation accuracy
• Strong organizational, analytical, and time management skills
• Ability to manage multiple priorities in a fast‑paced environment
• Strong math and unit conversion skills

Additional requirements:

• Ability to work effectively under pressure
• Successful completion of background check and drug screening

4) SUPERVISORY RESPONSIBILITIES

This position has no supervisory responsibilities.

5) CONSEQUENCES OF ERROR

This role supports products and processes that scale to commercial manufacturing. Errors may result in compliance risks, quality issues, production delays, or customer impact. A high level of accuracy and attention to detail is essential.

6) WORK ENVIRONMENT

Combination of office, laboratory, and manufacturing floor environment. Employees may be exposed to fumes, airborne particles, and occasionally moving mechanical parts or chemicals. Noise levels are typically low to moderate but may be occasionally loud. Appropriate safety protocols must be always followed.

7) PHYSICAL DEMANDS

• Ability to sit, stand, and perform routine office and laboratory tasks
• Occasional walking, bending, and stooping
• Ability to distinguish colors and detect odors as required for product evaluation
• Ability to stand for an entire shift to observe routine batching operation in support of Compounding.

8) POSITION TYPE/EXPECTED HOURS OF WORK

• Full‑time position, Monday through Friday
• May require occasional off‑shift support during manufacturing trials or troubleshooting activities.

9) TRAVEL

No travel is expected for this position.

10) REQUIRED EDUCATION & EXPERIENCE

• Bachelor's degree in chemical, Process, Industrial, or Pharmaceutical Engineering; Cosmetic or Formulation Science; or a related technical field.
• 3–5+ years of experience in cosmetic, personal care, OTC, pharmaceutical, or related GMP manufacturing environments.
• Experience with scale‑up and commercialization of cosmetic or OTC formulations is strongly preferred.
• Hands‑on experience troubleshooting liquid and semi‑solid manufacturing processes.
• Experience with emulsions, surfactants, alcohol systems, suspensions, and rheology modification preferred.
• Contract manufacturing (CMO) experience highly desirable.

11) PREFERRED QUALIFICATIONS

• Strong written and verbal communication skills
• Strong analytical and troubleshooting mindset.
• Ability to make sound technical decisions in fast‑paced manufacturing environments.
• Excellent communication and cross‑functional collaboration skills.
• Comfortable working directly on the production floor and in laboratory environments.
• Strong organizational and project management capability.
• Ability to manage multiple projects and priorities simultaneously.

12) ADDITIONAL ELIGIBILITY QUALIFICATIONS

• Proficiency in English, including grammar, composition, and technical writing
• Working knowledge of Microsoft Office (Word, Excel) and Adobe Acrobat

13) KEY PERFORMANCE INDICATORS EXPECTED (KPIs)

• First-pass batch success (Right the First Time) rate
• Reduction in batch failures and deviations
• OOS batch recovery success rate
• Scale‑up commercialization success
• Yield improvement
• Manufacturing cycle time reduction
• Scrap reduction