Description

Position Summary
The Process Engineer will help develop, configure and optimize manufacturing processes from inception through to start-up and validation (OTCs). They will provide daily technical service and leadership to the Operations group while collaborating with the Compounding and Packaging Supervisors, Quality, and R&I on day-to-day operations.

The Process Engineer will help support process validation activities and act as a liaison between R&I, Quality, and Compounding. This role is responsible for manufacturing the successful scale-up of first production batches of personal care, OTC, and Cosmetic products for BMSC. The candidate will be responsible for supporting technical transfer projects, as well as facilitating technology transfer from R&I into Operations. This role will also help optimize processes, batch sizes, and identify efficiency opportunities for ongoing production. The ideal candidate will demonstrate technical leadership and provide strong support; develop technical solutions to complex problems that require innovation and creativity; lead projects outside of the usual scope; regularly initiate innovative procedures, and make strategic recommendations to improve processes.

Responsibilities and Essential Duties

• Transform lab-scale processes, through pilot batches, to large-scale compounding of personal care, OTC, and color cosmetic products.
• Provide Process Engineering support and leadership to initiate and sustain continuous improvement of products and processes.
• Process development and troubleshooting during technology transfer with customers.
• Collaborate with R&I and Quality to carry out stability and compatibility testing of products under development.
• Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs, and changeovers.
• Establish best practices and innovative solutions to industrial processes in order to improve production rates and quality of output in processing operations efficiency improvements, reduce costs, improve sustainability and maximize profitability.
• Identify and resolve process deviations and Bulk or Raw Material non-conformances.
• Write, review, and maintain Quality documents, forms and records in the Operations areas.
• Perform multiple tasks and projects simultaneously and manage time efficiently and effectively in a fast-paced environment.
• Off-shift support as needed.

Qualifications

Technical Skills Required

• Effective oral and written communication skills and ability to appropriately communicate sensitive information in timely manner to all levels of the organization.
• Effective communicator with training, facilitation and supervisory skills.
• Strong analytical and problem-solving skills.
• Foster collaboration and results oriented.
• Self-motivation and ability to work with people at all levels of the organization.
• Computer skills to include proficiency with the Microsoft Office Software.

Experience Required

• Minimum 2 years in process engineering.
• Bachelor of Science Degree in Engineering or equivalent scientific field.
• Familiarity with cGMP, preferably in an FDA-regulated environment.
• Experience in FMCG environment (Cosmetic, Food, or Pharma).
• Experience with Processing requirements for Cosmetic and OTC products in line with cGMP and FDA 21 CFR 21 Part 210/211 procedures, and knowledge of Safety, and OSHA regulations.

Physical Requirements

• Must be able to move, transport, and position objects up to 25 pounds.
• Must be able to climb stairs, stand for long periods of time, and have the ability to bend.
• Able to use GMP-required garments and safety equipment as required by SOPs and GMPs.