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Operator Iii, Pharmaceutical Jobs

Company

Boehringer Ingelheim
Address , , Pr
Employment type FULL_TIME
Salary
Expires 2023-07-12
Posted at 1 year ago
Job Description
Perform tasks for the manufacturing of Pharmaceutical products following standard operating procedures and applicable regulations. Perform manufacturing tasks: operate and perform troubleshooting on equipment used in the manufacturing processes. This equipment includes but not limited to grinder, blender, forming machine, dryer, sieving, mixers, maturators, scales, cart lifters, auxiliary equipment. Perform the weighing of manufacturing ingredients including the subdivision of active ingredient. Perform the manufacturing of the intermediate formulation. Tasks include documentation including data entry and documents and/or use of computer systems. Comply with written procedures and Good Manufacturing Practices. Participate in Safety and Environmental inspections and audits. Operate computerized systems. Perform quality checks and sampling. Coordinate calibration of instruments and equipment maintenance. Perform reconciliation of materials and the inventory control using computerized system. It is required to wear protective equipment. Incumbent must be willing and available to work in rotating shifts, extended periods, and/or overtime when required.

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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Follows lock-out, tag-out procedures before intervening with equipment.
  • Evaluates process data and performs product sampling and inspections as part of the manufacturing process and quality monitoring.
  • 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.
  • Documents manufacturing and cleaning steps as per SOPs, batch records and batch official forms, including inspection, sampling and process monitoring.
  • 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.
  • 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.
  • Provides support in the auditing of the manufacturing batch records and related documentation.
  • 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 to requirements established in SOPs and lot documentation. Informs any deviation or potential deviation to the supervisor. Takes action as per procedures to avoid or minimize impact to the process or operations.
  • 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.
  • Participates in continuous improvement initiatives related, but not limited, to cost reduction, process optimization, quality level improvement, output increase.
  • 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.
  • 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.
  • Weights ingredients to be used in the manufacturing of product, including activities related to active ingredients like sieving, subdivision and intermediate formulation.
  • Assembles and disassembles mechanical equipment to execute cleaning tasks and process, as required.
  • 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
  • Segregates waste (dangerous, non-dangerous) according to procedures and guidelines. Performs environmental inspections to the waste area as required.
  • 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.
  • 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 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. Maintains the PPE in good conditions.
  • Complies with all the training required to perform the tasks, including SOPs, forms, guidelines, Safety and Environmental training.
  • 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.
  • Supplies materials to the manufacturing area as needed.
  • Performs other related tasks as required.

Requirements:

  • Able to document legible, precise and clear in documents following good documentation practices and cGMPs
  • Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notifications of any environmental and or safety events
  • Good communication skills, both verbal and written.
  • Knowledge on basic mathematical operations (sum, subtract, multiply, divide, percentage, fraction).
  • High school diploma is required; technical, associate or bachelor degree is preferred.
  • Proficient in Spanish (verbal and written) and basic knowledge in English (read and understand basic instructions).
  • 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.
  • Problem solving skills applicable to cGMP documentation.
  • Knowledge and experience working in a GMP environment, with good documentation practices, as well as product sampling and inspection.
  • Minimum of three to five (3-5) years of experience in pharmaceutical manufacturing required.
  • Knowledge of basic computer software: Word, Excel, Power Point, and other if needed.
  • Knowledge of Federal Regulations such as cGMP’s and EMEA.

Eligibility Requirements:

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

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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