Operator III, Pharmaceutical

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Operator III, Pharmaceutical will perform tasks for the manufacturing of Pharmaceutical products following standard operating procedures and applicable regulations. This role will perform manufacturing tasks such as operate and perform troubleshooting on equipment used in the manufacturing processes. This equipment includes but is not limited to grinder, blender, forming machine, dryer, sieving, mixers, maturators, scales, cart lifters, auxiliary equipment. The incumbent will perform the weighing of manufacturing ingredients including the subdivision of active ingredient.

The Operator III, Pharmaceutical will perform the manufacturing of the intermediate formulation. Tasks for this role include documentation including data entry and documents and/or use of computer systems. The incumbent will comply with written procedures and Good Manufacturing Practices. Additional responsibilities include participating in Safety and Environmental inspections and audits, operating computerized systems, performing quality checks and sampling, coordinating calibration of instruments and equipment maintenance, and performing reconciliation of materials and the inventory control using computerized system. It is required to wear protective equipment. The incumbent must be willing and available to work in rotating shifts, extended periods, and/or overtime when required.

Duties & Responsibilities

• Responsible for the manufacture of batches by operating manufacturing equipment and collects and/or evaluates process data as per written procedures, including product sampling during the manufacturing process.
• Assists in the troubleshooting and maintenance of manufacturing equipment, including grinder, granulators, scales, blenders, positive pumps, vacuum pumps, dust collectors, mixers, maturators, among others.
• Provides support to the mechanic in the reparation and maintenance of equipment according to specifications.
• Follows lock-out, tag-out procedures before intervening with equipment.
• Assembles and disassembles mechanical equipment to execute cleaning tasks and process, as required.
• Performs the cleaning and housekeeping of equipment, utensils, tools and areas, major and minor cleaning, according to establish procedures and documenting in the corresponding sheets.
• Uses correct identification as per procedures.
• Supports and/or participates in mechanic reparation and preventive maintenance, ensuring compliance with manufacturer specifications.
• Inspects manufacturing tools and utensils, maintaining them in good condition and maintaining related documentation.
• Performs the accountability of materials, ingredients and components in the different stages of the manufacturing process.
• Completes documentation, accordingly, following good documentation practices, cGMPs and SOPs. Returns materials and allocates waste in the respective designated areas.
• Weighs ingredients to be used in the manufacturing of product, including activities related to active ingredients like sieving, subdivision and intermediate formulation.
• Performs the cleaning and housekeeping of equipment, utensils, tools and areas, major and minor cleaning, according to establish procedures and documenting in the corresponding sheets.
• Uses correct identification as per procedures.
• Complies with standard operating procedures, batch records, production records, sheets, checklist and process related documentation.
• Supports in other quality related activities such as product evaluation, statistical sampling, microbiological sampling using aseptic techniques, and others as required.
• Alerts and informs the supervisor and group leader about any incident that could represent a risk or hazard for anyone or for the manufacturing process.
• Notifies immediately any accident or safety/environmental incident to the supervisor.
• Supplies materials to the manufacturing area as needed.
• Complies with all the training required to perform the tasks, including SOPs, forms, guidelines, Safety and Environmental training.
• Provides support in the auditing of the manufacturing batch records and related documentation.
• Keeps the areas cleaned and organized, including using the correct identification according to areas cleaning status.
• Removes material and product between batches according to procedures to avoid mix-ups or contamination.
• Alerts the supervisor about any potential safety hazard or contamination risk.
• Participates in continuous improvement initiatives related, but not limited, to cost reduction, process optimization, quality level improvement, output increase.
• Performs material transactions on the inventory system.
• Follows site general procedures and policies.
• Uses the personal protective equipment (PPE) required for the process or task to be performed.
• Uses the PPE in the right way, according to SOPs, Safety guidelines and training.

Requirements

• Responsible for the manufacture of batches by operating manufacturing equipment and collects and/or evaluates process data as per written procedures, including product sampling during the manufacturing process.
• Assists in the troubleshooting and maintenance of manufacturing equipment, including grinder, granulators, scales, blenders, positive pumps, vacuum pumps, dust collectors, mixers, maturators, among others.
• Provides support to the mechanic in the reparation and maintenance of equipment according to specifications.
• High school diploma is required; technical, associate or bachelor degree is preferred.
• Minimum of three to five (3-5) years of experience in pharmaceutical manufacturing required.
• Experience in manufacturing and/or materials handling process is required, including previous experience working with sampling plans, cGMP documentation and accountability of components, materials and product.
• Knowledge and experience working in a GMP environment, with good documentation practices, as well as product sampling and inspection.
• Able to read, write and speak Spanish. Basic knowledge of English (follow basic verbal and written instructions).
• Problem solving skills applicable to cGMP documentation.
• Knowledge on basic mathematical operations (sum, subtract, multiply, divide, percentage, fraction). 
• Knowledge of Federal Regulations such as cGMP’s and EMEA.
• Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notifications of any environmental and or safety events.
• Knowledge basic computer software: Word, Excel, Power Point, and other if desirable.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Desired Skills, Experience and Abilities

Additional Duties & Responsibilities:

• Maintains the PPE in good conditions.
• Collaborates in investigations on process deviations for the manufacturing area.
• Provides support in the implementation of corrective and preventive actions (CAPAs).
• Informs Health Services about any medical condition that could impact the performance of, others and/or the product being manufactured.
• Complies with environmental guidelines, SOPs, training, guidelines, practices, permit’s conditions, event internal notifications as required.
• Monitors process parameters to ensure that weight, temperature, pressure, humidity, or others are within limits and in accordance with requirements established in SOPs and lot documentation.
• Informs any deviation or potential deviation to the supervisor.
• Acts as per procedures to avoid or minimize impact to the process or operations.
• Segregates waste (dangerous, non-dangerous) according to procedures and guidelines.
• Performs environmental inspections to the waste area as required.
• Evaluates process data and performs product sampling and inspections as part of the manufacturing process and quality monitoring.
• Documents manufacturing and cleaning steps as per SOPs, batch records and batch official forms, including inspection, sampling and process monitoring.
• Assists technical personnel in equipment and process validation, including performing the required sampling according to approved instructions.
• Documents shift events and status in logs, as needed.
• Performs other related tasks as required.