Process Engineer

About the role

Optimizes products and processes by establishing process capabilities and controls and ensures adherence to standards through continuous verification. Leads site functional technical support for assigned dosage form as it relates to finding and implementing creative solutions that maximize value to our customers. Establishes specifications and appropriate process guardrails to ensure we deliver a reliable and repeatable process to Operations. Leverages data and an analytical mindset to draw insights on our products and champions change across our supply chain.

Responsibilities

• Demonstrates a high level of subject matter expertise for assigned dosage form and is capable of influencing internal and external groups to make improvements.
• Develops a high level of process understanding and capability for assigned dosage form, establishes appropriate level of controls for repeatability, and works to continuously optimize the product or process to maximize customer value.
• Uses problem-solving skills to identify root cause and implement short- and long-term corrective actions related to improving the reliability of our products or processes.
• Supports periodic review of our products and processes by collecting data, analyzing it, and making and implementing recommendations related to improvements.
• Supports Quality and Operations through troubleshooting, change controls, and Non-Conformance Report (NCR’s) reduction.
• Serves as a technical approver for equipment change requests and Installation Operations Qualification (IOQ’s) documentation.
• Prepares, reviews and/or approves technical documents to include but not limited to: Quality Change Requests (QCR’s), Non-Conformance Reports (NCR’s), Technical Reports, SOP’s, Master Batch Records (MBR’s), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols (IQ, OQ, PQ), P&PV Summary Reports and Stability Protocols.
• Serves as a cross-functional team lead who addresses specific problems, facilitates discussion and research, enabling manufacturing and packaging operations to become more efficient and to build and enhance interdepartmental relationships.
• Performs equipment testing and qualification as required, including factory acceptance test (FAT), site acceptance tests (SAT), performance qualification (PQ), Installation qualification (IQ) and operational qualification (OQ) activities.
• Ensures efficient operations in assigned project areas in accordance with Pharmavite Safety Requirements, SOP’s and GMP’s.
• Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury.

Qualifications

• Bachelor's Degree or equivalent work experience in Industrial Engineering, Mechanical Engineering, Chemical Engineering, Food Science, or other related science fields.
• 1–3 years related experience.
• Requires two years of industry experience (preferably in pharmaceutical, nutritional, food, or other consumer-packaged goods) in manufacturing technical support and/or process/product development, Quality Engineering and/or testing.
• Certified Packaging Professional, Lean Manufacturing, Six Sigma, or other related problem-solving tools is a plus.

Knowledge, Skills & Competencies

• Comprehensive knowledge of product and process development, manufacturing/packaging equipment, processing/testing laboratory techniques and regulatory requirements.
• A firm foundation in chemistry, mathematics, pharmaceutics and/or food science.
• Well-developed oral and written communication skills.
• Results-oriented and able to effectively organize and develop plans; prioritize and execute actions.
• Ability to make presentations and recommendations in assigned area.
• Understanding of Lean concepts and application of DOE and QbD are a plus.
• Use of hand-held data collection devices and instrumentation.

Physical or Work Requirements

Splits time between office-based work and manufacturing or operational environments. Employees are required to use computers and attend meetings while also regularly walking in production areas, climbing stairs or platforms, wearing PPE in operational spaces, and occasionally lifting or moving light materials or equipment. Work may occur in environments with manufacturing noise, moving equipment, temperature variation, or other operational conditions requiring safety precautions.

Travel

20% overnight travel for training or to support other regional facilities is anticipated. Up to 10% of routine travel to support other locations and up to 25% travel to support special/new projects.

Pay

National Target Base Pay Range: $80,000.00 – $133,000.00. For candidates in California and the New York metro, the Target Base Pay Range is $88,000.00 – $146,000.00. Actual compensation will take into account a wide range of factors unique to each candidate. Base pay is only one component of our total rewards offering.

Benefits

• Annual performance bonus
• Medical, dental, and vision benefits
• 401(k) match
• Other wellness benefits