Process Engineer

Job Summary

Responsibilities

Qualifications

Skills

Benefits

Pay

Schedule

Lead New and Continuous Process Improvement Projects, including identification of opportunities, researching literature and vendors for new technologies, preparing/presenting proposals, developing/executing projects, while following appropriate Management of Change (MOCs) methodologies.

Support day-to-day manufacturing operations as Technical Subject Matter Expert (SME) by investigating and resolving process related issues involving the manufacturing process or equipment/ systems.

Perform process monitoring of identified attributes and process parameters. Identifying trends and appropriate actions to continuously improve the process and product.

Provides training support as required.

Supports development of required cleaning processes for equipment trains.

Prepares documentation for new processes and process improvements including Management of Change (MOCs), Risk Assessments, Batch Records, Engineering Studies (ES) and Standard Operating Procedures (SOPs).

Develops a plan and leads product technology transfer and scale-up.

Determines process parameters at Pilot and Commercial Scale.

Evaluates process parameter variability on Critical Quality Attributes.

Establishes the product manufacturing control strategy and implements into Batch Records.

Finalizes the QTPP (Quality Target Product Profile).

Represents Engineering Subject Matter Expert (SME) in Product Development Teams.

Supports deviation investigations to identify root causes and define corrective and preventive actions (CAPAs).

Works with and manages outside contractors to provide support to projects.

Able to perform all duties efficiently and independently with minimal supervision.

Able to work within and lead in a team environment, consisting of multi-functional groups, to achieve a common goal, while promoting teamwork, timeliness, accuracy and compliance in all activities.

Able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies.

Qualifications

• Minimum 4-year degree in Chemical (preferred) or Mechanical Engineering, or equivalent pharmaceutical experience.
• 5-7 years of related experience; Pharmaceutical process development/ manufacturing experience preferred.
• Expertise in troubleshooting manufacturing processes, ideally with mixing and blending systems, thin film coating, packaging and web handling, and liquid dispensing.
• PC literate with standard office applications (Outlook, Word, Excel, PowerPoint, MS Teams) competency.
• Knowledge and experience in cGMPs, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge and experience in project management, including leading and development of capital funding requests and project management software (MS Project, WRIKE or similar).
• Strong communication skills, both written and verbal, and ability to adapt to changing priorities working both independently and collaboratively with teams, when required.

Skills

• Project Management
• Process Improvement
• Technical Troubleshooting
• Documentation Preparation
• Equipment Maintenance
• Team Leadership
• Communication

Benefits

• Bonus Eligibility
• Health Care and Other Insurance Benefits (for Employee and Family)
• Retail Benefits
• Paid Holidays
• Vacation
• Sick Days

Pay

Details about pay are not specified in the job posting.

Schedule

The position requires 24-hour support for manufacturing and may be required to work extended hours to support operations or projects.