Formulator

Plastikon Healthcare is looking for a Formulator to support the primary manufacturing operation of formulating solutions, transferring solutions, batching, mixing, cleaning equipment of the BFS and BFC batching systems by operating processes, machinery, and formulation equipment, assure compliant to the cGMP’s, monitoring and perform activities to keep the process/machinery, formulation areas, tanks/vessels, utensils and ancillary equipment related to formulation activities, meeting the process and maintenance requirements, support other areas as needed. Follows the designated procedures and policies applied by Plastikon Healthcare. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions

Job Roles required of the position:

The Formulator is capable to run, execute as per process requirements and specifications all batching, mixing, formulation and water generating systems, this role is masterpiece in execution of the manufacturing batching record for all aseptic fill formulation systems for BFS and BFC manufacturing lines:

• CIP skid and water generation system, able to perform valves opening as required, water distribution and perform CIP to all aseptic fill systems. This may include BFS machines, BioFire line and BFC batching equipment.
• Able to operate the computerized management system for water generation, CIP, mixing, filling, and transferring set up.
• Support the senior formulator lead with PW generation system and all subsystems associated.
• Support the senior formulator lead in operating steam generator system.
• Able to support in the execution of preventive maintenance in vessels, utensils, tanks and operating valves, changing diaphragms, and any other related maintenance activities in accordance with the applicable SOP.
• Able to perform cleaning and sanitization of facilities areas as required.
• Able to perform sampling for all solutions, formulation and water testing as required by process/product requirements.
• Other duties as assigned.

Essential Functions:

• Able to identify all risk and safety conditions that can compromise the operator’s wellbeing and process/machinery equipment.
• Complete master batch record (MBR). Actively completes batch record paperwork and documents for compliance with requirements, assuring all logbooks are up to date.
• Execution of area line clearance before and after any formulation activities.
• Manage and control all raw materials on applicable storage room, staging room and formulation areas. Keep clean records of all raw materials reconciliation, including stock on hand, expiration dates and cycle counts.
• Responsible for upkeeping clean transfer systems, method for moving raw materials from storage room, weigh area to a mixing vessel via sanitized transfer hose or by any other applicable method, assuring cleanliness and free of contamination.
• Execution of the computerized management system for water generation, CIP, mixing, filling, and transferring set up according to the solution/formulation recipe.
• Responsible for identification of equipment, process and raw materials tagged in accordance with the applicable process steps when the MBR is under execution.
• Responsible to track and keep records of all vessels/tanks remaining product after filling for traceability and reconciliation.
• CIO/COP execution and all required equipment, including tanks, vessels, utensils, hoses, and any other product path asset required for formulation, transfer, and filling system.
• Responsible for the execution of integrity test system, providing support to the aseptic fill system technician.
• Direct support in the execution of heat treatment for PW system and tank according to the applicable SOP.
• Provide additional support for the execution of preventive maintenance in all stainless-steel process tanks.
• Provide support to maintenance department with the operation and maintenance of CIP systems.
• Provide support for the execution of preventive maintenance in RO generation systems.
• Provide support for maintenance of floor and portable scales in use for formulation activities.
• Responsible for collecting rinse sampling and product sampling for any solution, formulation or water testing.
• Responsible for cleaning and sanitization of formulation, storage and stating areas according to the schedule and requirements.
• Follow-up and execution of the production schedule.
• Collaborates with operational personnel (line leader, supervisor, engineering, leader, and maintenance technicians, etc.), in monitoring and supporting the production plan.
• Conduct process control and adjust, if necessary, based on the operations SOP, taking into consideration the performance of the process.
• Print and manage labels as part of the production schedule.
• Monitor the process and operating systems. Able to elaborate production daily reports and capture production numbers into the ERP system IQMS.
• Provide and support training to other technicians, create training material.
• Create records and support the production management team to maintain positives trends on all operations KPI’s.
• Perform 5’s in accordance with the best manufacturing practices.
• Ensure the quality of the product by following the cGMP and Plastikon Healthcare Policies.
• Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities.
• Follow the escalation path and communication process to solve process and machinery issues.
• Create daily productivity reports, downtime and any other related KPI from assigned areas as part of standard job.
• Support the continuous improvement.

cGMP’s and Documentation System Responsibility

Follow the cGMP’s as per the quality manual to assure compliance with all applicable systems and regulations by keeping all logbooks, procedures, and standards up to date in accordance with Plastikon Healthcare Policies. Keep legible records, assuring a 100% compliance in accordance with cGMP and cGDP.

Safety Requirements

Follow all safety regulations and PPE in accordance with Plastikon Healthcare regulations and policies. Notify any safety condition related to the job and assigned area. Support EHS and operation team to improve safety conditions.

Minimum Experience:

• 3 - 5 Years
• Microsoft office – advanced skills for reporting and creating presentations.
• Time availability to work with different shifts.
• Previous experience with ISO 13485 and QSR.
• Previous experience with FDA cGMP’s.
• Quality systems training.
• Lean manufacturing.
• Lean six sigma.
• Previous experience in supply chain systems.
• Experience with inventory management.
• 5’s applied to daily basis job.
• APICS training or previous experience is a plus.
• Previous experience with ERP systems.
• IQMS.
• Teamwork
• Analytical Skills
• Decision Making
• Communication skill
• Problem Solving
• Detail Oriented & Service Oriented
• Communication
• Customer Approach
• 365 Office Package

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Competencies & Behaviors

• Self-Management
• Work Ethic and Integrity
• Accountability
• Intellectual Curiosity
• Productive and Results Oriented
• Leadership – Teamwork
• Leadership – Develop Others

#HPJobs

Job Type: Full-time

Pay: $20.00 - $22.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person

Salary : $20 - $22