Job Description
Position Summary
The Compounding Process Expert will help to configure and optimize manufacturing processes and corrections for all scheduled batches in Compounding. They will provide daily technical service and leadership to the Compounding group while collaborating with Compounding, Quality, and R&I on day-to-day operations.
The Compounding Process Expert is the primary liaison between R&I, Quality, and Compounding and is responsible for supporting the successful production of batches of personal care, OTC, and Cosmetic products for BMSC. This role will also optimize processes, batch sizes, and identify efficiency opportunities for ongoing production. The candidate will primarily be responsible for leading the support of multiple technical transfer projects, as well as facilitating technology transfer from R&I into Operations.
Responsibilities and Essential Duties
Provide Compounding Process Expertise support and leadership to initiate and sustain continuous improvement of products and processes.
- Provide process development and troubleshooting during technology transfer with R&I Team.
- 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 improvement, reduce costs, improve sustainability, and maximize profitability.
- Train Compounders and Supervisors on new processes and procedures.
- Develop and monitor key metrics including efficiency, right the first time, water usage, etc.
- Represent the site during Regulatory, external, and internal audits and inspections.
- Identify and resolve process deviations and Bulk or Raw Material non-conformances.
- Write, review, and maintain Quality documents, forms, and records in the Compounding areas.
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 training, facilitation, and supervisory skills.
- Strong analytical and problem-solving skills.
- Foster collaboration and be results-oriented.
- Courageous leader.
- Self-motivated and able to work with people at all levels of the organization.
- Computer skills to include proficiency with Microsoft Office Software.
Experience Required
- Minimum 7 years in process engineering.
- Bachelor of Science Degree in Engineering or equivalent scientific field (advanced degree a plus).
- 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 Part 210/211 procedures, and knowledge of Safety, and OSHA regulations.
Physical Requirements
- Must be able to move, transport, and position objects up to 30 pounds.
- Must be able to climb stairs, stand for long periods of time, and have the ability to bend.
- While performing the duties of the job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts, loud noises, and vibration.
- Incumbent is subject to other hazards such as moving mechanical parts, electrical current, chemicals, and heat.
- Able to use GMP-required garments and safety equipment as required by SOPs and GMPs.