Job Description

PRIMARY PURPOSE: 

Responsible primarily for the manufacturing process development, process validation, cleaning validation, and commercialization of new products from a process engineering perspective.  This role may also include providing engineering services for full product life cycle including process robustness review, process optimization initiatives, product equipment transfers, annual product reviews, material changes, capital projects, and commercial product manufacturing technical support.

MAJOR DUTIES AND RESPONSIBILITIES: 

• Lead technical aspects of assigned projects aimed at commercially developing and launching new products, including but not limited to conducting manufacturing feasibility assessments, technical reviews and risk assessments, manufacturing process flows, pilot batch manufacturing, authoring batch records, protocols and reports and conducting process-related laboratory experiments.
• Accountable and responsible for delivering assigned projects and related milestones on-time, in-full and right-first-time, with a mindset towards Excellence in execution and Quality-By-Design.
• Write SOPs, as needed, to support new products and utilize lean and/or Six Sigma tools to generate process improvements for new and existing products.
• Conduct training with manufacturing operators and provide on-the-floor support during batch manufacturing for new products, including performing technical investigations for non-conforming product or manufacturing deviations.
• Independent management of new product transfers, performing equipment fit and gap analyses, and authoring critical documentation such as Risk Assessment, OOS Investigation, Process Development & Validation protocols, Cleaning Development & Validation protocols, etc.
• Focused on process development and design for new products, as well as process optimization for recently launched products in all phases of the manufacturing process (blending, filling, packaging, etc) using Quality-by-Design principals and lean/Six Sigma tools for optimal impact.
• Generate technical reports, specifications, and other supporting documentation as needed.
• Coordinate with outside vendors, contract labs, and equipment manufacturers as needed to support project or related work deliverables.
• Support business with strategic analysis and proactive concept development for manufacturing process optimization projects.
• Collaborates across various departments like Manufacturing, Quality, R&D teams, Engineering, Supply Chain, Procurement, and Project Management to ensure project success.
• Generate/maintain documents and provide related technical support related to GMP Manufacturing executions, product impact assessments and periodic reviews.
• Participate in the project team meetings, decisions, and creation of milestones representing process engineering.
• Process training, as needed, in adherence to company policies and quality requirements.
• Evaluate, define, and provide user requirements for process equipment associated with drug product manufacturing.
• Prepare and present data associated with manufacturing processes to internal and external teams as required.
• Keep current on regulatory and quality requirements for manufacturing, including FDA-regulated products and cGMP compliance.
• Interacts regularly with senior technical peers and colleagues. 
• Other duties may be assigned, at the discretion of management.

QUALIFICATIONS: 

• Bachelor’s degree in chemical engineering or relevant experience  
• At least 2 years of process engineering experience in the pharmaceutical/chemical manufacturing industry, preferably with cGMP manufacturing of FDA-regulated drug products, is strongly preferred.

CRITICAL SKILLS AND ABILITIES: 

• Demonstrated ability for independent work, thought, and analysis.
• Demonstrated strong technical expertise and ability to adapt to changing circumstances with proposed contingency plans to support the business.
• 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.
• 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 able to work extended hours on evenings and weekends as required.  
• Must be capable of detailed record keeping and communicating results to others.
• 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.

COMPUTER SKILLS: 

• Proficient with Microsoft Office 365, including Teams, Word, Excel, and PowerPoint.
• Minitab experience is preferred but not required.

PHYSICAL DEMANDS: 

• 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, safety glasses, and respirator when required.
• Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.  
• Must be able to work extended hours on evenings and weekends as required.