Process Engineer

PRIMARY PURPOSE:

Provide engineering services for full product life cycle including process robustness review, process optimization initiatives, product equipment transfers, process validations, cleaning validations, material changes, and commercial product manufacturing technical support.

MAJOR DUTIES AND RESPONSIBILITIES:

• Independent management of product transfers, performing equipment fit and gap analyses, and authoring critical documentation such as Risk Assessment, OOS Investigation, Process Validation protocols, Cleaning Validation protocols, etc.
• Focused on process optimization in all phases of manufacturing process (blending, filling, packaging, etc) using lean or six sigma tools for optimal impact.
• Lead and/or support cleaning validation and process validation efforts and projects, as needed to support commercial operations.
• Identify and lead continuous improvement engineering projects to enhance process robustness, manufacturing efficiency, and deviation reduction through engineering controls.
• 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.
• Provide day-to-day technical support for commercial manufacturing. Conduct technical investigations, write reports, and aid in the close-out of deviations.
• 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, 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 functions as required to support existing operations and client-driven projects.

QUALIFICATIONS:

• Bachelor's degree in chemical engineering or relevant experience
• At least 2 years of process engineering/technical services/MS&T experience (preferably 5 years) in the pharmaceutical/chemical manufacturing industry, preferably with cGMP manufacturing of FDA-regulated drug products.

CRITICAL SKILLS AND ABILITIES:

• 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.
• 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 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.