Process Engineer

About the role

This role is not available for any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT.

Responsibilities

• Demonstrates a high level of subject matter expertise for the assigned dosage form and is capable of influencing internal and external groups to make improvements
• 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
• Develops a high level of process understanding and capability for the assigned dosage form, establishes an appropriate level of controls for repeatability, and works to optimize the product or process to maximize customer value
• Supports periodic review of our products and processes by collecting data, analyzing it, and making and implementing recommendations related to improvements
• Serves as a technical approver for equipment change requests and Installation Operations Qualification (IOQs) documentation
• Prepares, reviews, and/or approve technical documents to include but not limited to: Quality Change Requests (QCRs), Non-Conformance Report (NCRs), Technical Reports, SOPs, Master Batch Records (MBRs), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols (IQ, OQ, PQ), P&PV Summary Reports and Stability Protocols
• Serves on cross-functional team leads who address specific problems, facilitates discussion and research, enabling manufacturing and packaging operations to become more efficient and to build and enhance interdepartmental relationships
• Maintains documentation on all projects and submits written reports in a timely fashion
• Performs equipment testing and qualification as required. Will support the following: factory acceptance test (FAT), site acceptance tests (SAT), and performance qualification (PQ), will also require participation in Installation qualification (IQ) and operational qualification (OQ) activities
• Trains Technical Operations, Product Development, and Manufacturing staff on new processes and/or equipment technologies
• Ensures efficient operations in assigned project areas in accordance with Pharmavite Safety Requirements, SOPs, and GMPs. Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury
• Reviews current and new processes; applies state-of-the-art technology to our processes
• Occasional after-hours operations and or project support may be required
• Performs other related duties as assigned

Requirements

Requires a four-year college or university degree in Industrial Engineering, Mechanical Engineering, Chemical Engineering, Food Science, or other related science fields.

Certified Packaging Professional, Lean Manufacturing, Six Sigma, or other related problem-solving tools are a plus.

Requires two years of industry (preferably in pharmaceutical, nutritional, food, or other consumer-packaged goods) experience in manufacturing technical support and/or process/product development, Quality Engineering, and/or testing.

Qualifications

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.

The ability to make presentations and recommendations in the assigned area.

Understanding of Lean concepts and application of DOE and QbD are a plus.

Use of hand-held data collection devices and instrumentation.

Skills

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.

The ability to make presentations and recommendations in the assigned area.

Understanding of Lean concepts and application of DOE and QbD are a plus.

Use of hand-held data collection devices and instrumentation.

Benefits

Health and wellness begins with us.

Pharmavite is an equal opportunity employer.

We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law.

We also prohibit employment discrimination and harassment based on a sincerely held religious belief, in accordance with applicable laws.

Pharmavite recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities.

Our total rewards package for this position may also include an annual performance bonus, Medical, dental, and vision benefits, 401(k) match, and other wellness benefits.

Visit Pharmavite.com/careers to learn more about our mission and discover an opportunity that's right for you.

Pay

National Target Base Pay Range: $80,000.00 - $133,000.00.

The salary range for this position is based on national standards.

For candidates in California and the New York metro, the Target Base Pay Range is $88,000.00 - $146,000.00, to reflect the cost of living and market conditions in those areas.

Actual compensation will take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location, education, experience, qualifications, and job-related skills.

It is not typical for an individual to be hired above the midpoint of the range for their role, and compensation decisions depend on the facts and circumstances of each case.

This information is provided to applicants in accordance with state and local laws.

Base pay is only one component of our total rewards offerings, and we will take the full offering into consideration when presenting an offer of employment.

Schedule

Manufacturing, Pilot Lab, and general office environment, which may occasionally require lifting up to 35 lb.

Frequent work in pilot plants and production facilities.

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

Safety: The incumbent must be able to perform this job safely in accordance with standard operating procedures and good manufacturing practices, without endangering their own or others' health or safety.

Supervisory Responsibility: Guides and assigns the work of Technicians, and may include coordinating and supervising outside engineers/vendors and technical support personnel.