Formulation Specialist I – Pilot Facility

States considered: Michigan

Role Description

POSITION SUMMARY

The Pilot Facility (PF) Formulation Specialist supports the Oral Solid Dose (OSD) Pilot Facility by preparing, assembling, operating, and cleaning manufacturing equipment for animal health products. This role demands meticulous attention to detail, adaptability to new processes, adherence to manufacturing standards, and strong communication and teamwork skills.

POSITION RESPONSIBILITIES

• Support Pilot Facility small scale batch production.
• Ability to understand and operate all manufacturing equipment in PF. Become proficient in blending and weigh/dispense, tableting, granulation, roller compaction and all associated equipment
• Operate, maintain, troubleshoot and make minor repairs on Pilot Facility equipment
• Work with Project leaders by participating in batch planning, manufacture, and follow up. Effectively communicate issues regarding process, materials and personnel to the Project leader or Pilot Facility Director.
• Set up batch equipment and supplies for manufacture
• Clean rooms and equipment and leave ready for next manufacture in appropriate state of cleanliness
• Become proficient at tablet and powder in-process test equipment such as Tap Density, LOD, Disinegration, Hardness, Friability, Mass Flow etc.
• Review completed batch records to ensure correctness, compliance with GMPs, etc.  Work with team to correct errors and on batch record structure/content for improvement/error reduction.
• Scan and organize batch records for on- and off-line access
• Participate in Project team meetings, SOP revision, Continuous improvement for the area and projects, etc
• Train new specialists
• Ensure all tasks are performed in accordance with applicable batch records, standard operating procedures (SOPs) and safety guidelines, as well as applicable regulatory standards, such as current Good Manufacturing Practices (cGMPs)
• Assembly, disassembly, and proper cleaning of Pilot Facility equipment and work areas
• Ability to train on area SOP’s/OJT’s- equipment, process, paperwork.
• Capable of collecting and assembling data for review.
• Ability to work with hazardous materials in a controlled manner by following proper gowning procedures, all SOPs, and safety guidelines
• Follow specific and detailed recipe instructions, requiring “right first time” measuring and mixing of ingredients to create finished products
• Monitor, evaluate and adjust processes or equipment to maximize quality and efficiency
• Maintain complete and accurate documentation of all tasks completed
• Effectively communicate with Project leaders, support personnel and area leadership

TECHNICAL SKILLS REQUIREMENTS

• Knowledge of cGMP’s and production practices
• Experience in a Lean Production and/or manufacturing environment
• Reliable transportation and good attendance/time management skills
• Experience in Lean Manufacturing and continuous improvement work environment; 5S, visual schedule, PDCA, M1, etc.
• Ability to train on area SOP’s/OJT’s- equipment, process, paperwork
• Experience in working with Tech Writer, creating and maintaining training documentation

EDUCATION AND EXPERIENCE

• High school diploma or general education degree (GED)
• Basic math and legible writing, reading comprehension
• 2-5 years of relevant pharmaceutical or packaging experience
• Demonstrated Mechanical reasoning and troubleshooting skills
• Ability to follow detailed instructions
• Effective interpersonal communication and a positive outlook
• Mechanical reasoning and troubleshooting skills
• Knowledge of cGMP’s and production practices
• Computer Skills:  Microsoft Applications preferred
• Individual must be self-motivated and be able to work independently
• Good oral and written communication skills

PHYSICAL REQUIREMENTS

The work characteristics described here are representative of those a colleague encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the colleague is regularly exposed to a manufacturing environment, including moving mechanical parts. The work conditions for this position are 100% standing and walking throughout the workday and require routing lifting of 20-50lbs. The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety (“steel-toed”) shoes, eye protection, gloves, PAPRs, and protective clothi