Process Engineer

Otsuka Pharmaceutical Co., Ltd; United States; Hybrid; USD 80,000 - 133,000; Full time

Benefits offered by this job

Annual performance bonus

Medical/dental/vision benefits

401(k) match

Total rewards

Job summary

MegaFood is seeking a process-focused engineer to optimize dosage form processes, establish guardrails, and drive value across the supply chain. You will leverage data analytics to identify root causes and deliver repeatable improvements that benefit Operations and customers.

Responsibilities include developing process understanding, supporting qualification tests (IQ/OQ/PQ), controlling changes, and coordinating cross-functional efforts while maintaining GMP and safety standards.

Qualifications

• Bachelor's degree in Industrial, Mechanical, Chemical Engineering, Food Science, or related science.
• 1-3 years related experience; 2+ years in manufacturing technical support or process development a plus.
• Certified Packaging Professional, Lean Manufacturing, Six Sigma, or related problem-solving tools a plus.

Responsibilities

• Demonstrates subject matter expertise for assigned dosage form and influences groups to improve.
• Develops process understanding and controls for repeatability; optimizes product/process to maximize value.
• Uses problem-solving to identify root causes and implement corrective actions for reliability.
• Collects and analyzes data to review products and processes and recommends improvements.
• Supports Quality and Operations through troubleshooting, change controls, and NCR reduction.
• Prepares and approves technical documents (QCRs, NCRs, SOPs, MBRs, IQ/OQ/PQ).

Skills

Process development

Regulatory compliance

Quality and testing

Communication skills

Lean/DOE/QbD know-how

Education

Bachelor's degree or equivalent

Tools

IQ/OQ/PQ documentation

Job description

MegaFood, a Certified B Corporation and 1% for the Planet member, leverages 50+ years of scientific experience to thoughtfully craft quality supplements made with real food & nutrients that your body knows how to absorb. Since our founding in 1973, MegaFood has been committed to providing people safe, high quality supplements and takes food safety and quality seriously. MegaFood products are tested for 150+ pesticides, are NSF GMP certified and are made without the top 9 food allergens (milk, eggs, peanuts, tree nuts, soy, wheat, fish, shellfish, and sesame). MegaFood is also Certified Plastic Neutral through its partnership with rePurpose Global and has enabled recovery of over 740,000 pounds of nature-bound plastic since it became certified in 2023.

Learn more at megafood.com or follow @megafood on Instagram, @realmegafood on TikTok and @MegaFood on LinkedIn.

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.

Position Summary

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.

Key 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.
• 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.
• 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.

Compensation and Benefits

We are committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being -- as well as peace of mind. These rewards -- plus our new recognition program -- ensure employees feel supported both at work and home. 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. 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. MegaFood is committed to cultivating and preserving a culture of diversity, inclusion and belonging. The collective sum of our individual differences, knowledge, life experiences, and unique talents, represents a significant part of our culture and is the foundation for our accomplishments and impact.

Equal Opportunity and Diversity

MegaFood 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. MegaFood recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities. MegaFood also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws.

California Fair Chance Act

Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

About MegaFood

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! MegaFood has been crafting high-quality supplements for over 50 years, formulated with science-backed nutrients and real food. With a careful blend of both, we combine premium, research-backed ingredients to craft supplements designed for absorption to provide the support that you’re looking for. Quality is in our nature. MegaFood products undergo quality assurance testing in ISO 9001-certified laboratories and independent third-party labs. Our testing includes screening for over 150 pesticides, heavy metals, and identity verification to confirm ingredient integrity. That’s the MegaFood Way. We know that healthy people and a healthy planet go hand in hand, which is why we are deeply committed to improving our environmental footprint and amplifying our social impact. That’s why we are a proud B Corp and member of 1% for the Planet, as well as Certified PlasticNeutral. Through our partnership with rePurpose Global, we have supported the recovery of over 740,000 lbs of nature-bound plastic waste since 2022, and have a goal of moving to 100% recyclable, compostable or reusable packaging in the near future. Learn more at megafood.com or follow us on Instagram, Facebook, TikTok and LinkedIn.