Production Process Engineer
We are seeking a Production Process Engineer. This is an ideal role for a recent graduate or engineer early in their career looking to gain hands-on experience in a regulated manufacturing environment.
Summary
The Production Process Engineer supports the development and optimization of filling and packaging processes used in the manufacturing of personal care and OTC drug products. This role focuses on filling technologies for low- to high-viscosity liquids and semi-liquids while ensuring compliance with cGMP, FDA requirements, and customer specifications in a high-mix, fast-paced manufacturing environment. Emphasis on enhancement of efficiency, reduction of costs, and improvement of product quality and safety. Key responsibilities include conducting risk assessments, testing and monitoring equipment, updating current system processes, and ensuring product compliance.
Key Responsibilities include:
- Carry out responsibilities in compliance with company policies, work procedures, and federal, state and local laws. Comply with Good Manufacturing Practices (GMPs), and health and safety rules and regulations
Packaging Process Development & Support
- Assist in the development and improvement of filling and packaging processes for personal care and OTC products.
- Support production line setups, changeovers, trials, start-ups, first production runs and validations.
- Establish critical process parameters to ensure fill accuracy, repeatability, product integrity, and waste reduction.
- Review and support process validation needs as necessary.
Packaging Equipment & Line Optimization
- Drive continuous improvement initiatives to improve throughput, OEE, and changeover efficiency while reducing scrap.
- Troubleshoot fill weight variation, foaming, leakage, torque issues, and component compatibility challenges.
- Provide engineering support for filling lines, including fillers, cappers/torquers, induction sealers, labelers, conveyors, etc.
- Specify and support installation and qualification (IQ/OQ/PQ) of filling and capping equipment.
- Support cost-saving projects related to packaging materials and processes.
- Collaborate with Operations and Quality leaders to identify potential areas of process and product variability, address root causes and implement improvements to ensure the flow of quality products through the supply chain.
Compliance & Documentation
- Develop and maintain SOPs, work instructions, process flow diagrams and documentation for filling operations.
- Support deviation investigations, CAPAs, and change controls related to filling and packaging processes.
- Assist with packaging specifications, bills of materials (BOMs), and validation documentation.
- Ensure compliance with cosmetic regulations, OTC labeling, fill volume requirements, product integrity, safety standards, and internal quality systems.
Cross-Functional Support
- Collaborate with Production to support daily filling and packaging operations.
- Collaborate with Quality to ensure filling and packaging processes meet GMP and quality standards.
- Champion training of Operators and Mechanics on new or modified filling processes and equipment.
- Support Sales, Account Management, Purchasing, and R&D with new product introductions and packaging changes
- Assist in coordinating activities with packaging suppliers and vendors.
- Contribute to an environment in which all team members are respected regardless of their individual differences.
- Maintain a positive and productive relationship with co-workers and others with whom the position may have contact.
- Perform other duties as assigned.
Requirements
To fulfill requirements of job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree in Engineering (Packaging, Mechanical, Industrial, Chemical) or a related field.
- 1-2 years of experience in manufacturing, packaging, or engineering (internships experience acceptable).
- Experience in personal care, cosmetics, food, or pharmaceutical manufacturing is a plus, but not required.
- Basic understanding of manufacturing or packaging processes.
- Strong technical documentation, problem-solving, and communication skills.
- Ability to work effectively in a team environment.
- Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint, Visio).
- Fluency in English required. Bilingual proficiency in Spanish is a strong differentiator.
- Must be able to work in person onsite, including the flexibility to support off-shift production, weekend operations, and production trials or launches.
Physical Requirements and Work Environment
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Work is performed primarily in an active production environment with exposure to moving mechanical equipment and varying temperatures and humidity. The noise level is usually moderate.
- Regularly required to stand, walk, sit, reach with hands and arms and occasionally stoop, kneel, and crouch. Specific vision abilities required include close vision, depth perception, and ability to adjust focus.
- Required to wear all assigned PPE, which may include safety glasses or goggles, hearing protection, gloves, hairnets, beard covers, lab coats or smocks, slip-resistant footwear, and respiratory protection where required.
The compensation range for this role is $71,000 - $85,600 per year. Compensation is commensurate with level of knowledge, education, skills, and experience applicable to the position.
We understand that each team member's situation is unique, and so it is our intent to offer an overall benefits package that can be shaped and molded by each individual to fit their family's needs. Our current benefits package, which is available to all full-time team members, includes medical, dental, vision insurance, 401k retirement plan, flexible spending accounts, life and disability coverage, and other voluntary benefits.
We want everyone to feel welcome, respected and we are committed to providing the best space, experience and workplace for our teams - no matter what race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status and all the other fascinating characteristics that make us different.
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