A Process Engineering III is responsible to provide technical support for the manufacturing of tablets and capsules for commercial distribution and clinical trials. Personnel in this position will provide technical assistance that will include but not be limited to the following: troubleshooting current validated processes, process deviations and investigation, transfer of new process and technologies into Company and write appropriate documentation to support all validation and process transfer activities. These functions will be executed by following standard operating procedures, batch records in accordance with FDA current Good Manufacturing Practices. Will train and mentors others in the organization.
Key Job Responsibilities:
Provide technical assistance for process transfer and validation efforts for assigned manufacturing and packaging projects.
Composes process validation, cleaning validation, or process optimization protocols.
Clearly and accurately document activities.
Perform moderate to complex math calculations.
Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Write validation and technical improvement reports with no approval authority.
Provide input to Master Batch Records (MBRs). (equipment, critical process parameters, in-process tests, etc.)
Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
Assist technicians in performing physical testing during the manufacturing and packaging operation (e.g. sieve analysis, tap and bulk density, cap torque testing, etc.).
Mentor through instruction lower level engineers.
Lead investigations and complete CAPA assignments.
Essential Job Requirements:
B.S. in Engineering, Pharmacy or Chemistry or another degree deemed appropriate.
8+ years in pharmaceutical manufacturing environment or equivalent regulated industry.
Excellent understanding of pharmaceutical manufacturing and packaging of solid dose manufacturing.
Excellent understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of solid dosage forms spanning the entire product life-cycle.
Excellent understanding of applicable SOPs.
Excellent understanding of safety policies.
Safety - Ability to wear Personal Protective Equipment (including gowning and powered respirators). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled materials.
Quality Control – Quality Control – Ability to work with QA to effectively resolve issues and maintain an environment that is of the highest quality.
Regulatory Compliance – The ability to work in a regulated environment (FDA / DEA / OSHA) and strictly follow procedures.
Communication - Effective verbal and written communication. Ability to read and comprehend detailed written instructions.
Documentation – Clearly and concisely documents all work activities in a timely manner and writes appropriate reports..
Data Handling – Advanced computer skills (Excel, PowerPoint). Strong analytical skills. Collect data, evaluate its relevancy, conduct comparative and statistical evaluations and present it in a professional manner including graphs and charts.
Client Interaction – Interacts with clients on a regular basis.
May directly interact with auditors during scheduled inspections.
Teamwork – Ability to work effectively within a team environment. Capable of working across boundaries in the organization.
Leadership – Trains and mentors others.
Certifications: Certified Trainer.
Supervision Received: General
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.
The physical demands described here are representative of those that must be met by an employee to successfully perform 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 employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee 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 employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow and other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.