Description: Assure that products manufactured in the Integrated Process Team (IPT) comply with the highest standards of quality and in compliance with operating procedures, regulations and good manufacturing practices. Direct, supervise and control a group of hourly personnel engaged in the manufacturing and/or packaging process. Maintain control of all safety and environmental aspects of the operations. Responsible for: motivating, training and development of personnel under his/her supervision; work performance, scheduling and task coordination; equipment and area preparation; complying with formula requirements. Administer personnel policies and procedures. 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: Ensures materials receiving and verification in the area; equipment cleaning and set-up; and area cleaning and verification are done as per procedures. Assures that materials are properly handled and equipment is properly operated according to SOPs, guidelines, and regulations. Maintains control of processes and products quality by developing appropriate procedures and ensuring the compliance with cGMP's, safety and environmental. Monitors the packaging processes during the shift. Performs the approval of the expiration date calculation for the packaging process as needed. Responsible for the enforcement and compliance of safety practices, cGMP's, environmental, health, local and federal labor and industrial regulations, as well as OSHA regulations in his/her area of responsibility. Participates in external and internal audits and inspections. Supports investigation when a quality and/or safety event occurs in his/her shift. Works in the proper handling of quality issues in his/her shift, in coordination with the Quality Auditor and GMP Technician. Ensures that corrective actions are implemented. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence and lean practices. Responsible for ensuring that the personnel under his/her supervision are properly trained in cGMP's, procedures, good documentation practices and regulatory matters (safety, environmental, compliance). Monitors personnel practices to ensure compliance with SOPs, practices and regulations. Participates in the design, implementation and delivery of training and development programs. Supervises non-exempt/hourly employees, promoting their motivation. Mentors members under his/her supervision, provide input and coaching on professional development and career path; provide timely feedback, evaluate performance of direct reports after obtaining the relevant functional input and evaluation. Complies with all environmental guidelines, procedures, training, practices, permits conditions, and internal notification of any environmental events. Monitors regulatory parameters associated to instrumentation or equipment to ensure compliance with permits and environmental operations such as temperature, pressure, drops, etc. Segregates, labels and handles packaging waste and ensures appropriate disposition. Operates appropriately all control equipment to ensure compliance with environmental permits, plans and regulations. Coordinates maintenance and calibration of instrumentation and coordinates maintenance of facilities and equipment. Monitors all regulatory parameters or other associate parameters. Maintains regulatory documentation. Performs other job-related duties as required. Requirements: Education and/or Experience Bachelor Degree, preferably in Business Administration, Science (including Pharmacy), or Engineering More than two (2) years of experience in Manufacturing/Packaging, Operations, Business, Quality, preferably in a highly regulated manufacturing environment, such as pharmaceutical or medical devices. Concurrently, at least two (2) years of supervisory experience. Willing to work in irregular and/or rotating shift. Technical/Professional Expertise Communicates clearly and concisely in English I Spanish, orally and written Uses strong visual and verbal communications skills to communicate facts, figures, and ideas to others Knowledge of cGMPs and Safety regulations Computer Knowledge Microsoft Office applications, Statistical analysis software and other programs related to function. Experience in SAP is highly desired. Licenses and/or Certifications Required Reporting Relationship Reports to: Packaging Manager Positions Reporting to IPT Supervisor: Non-exempt packaging operators Receives Functional Guidance from: Process Leader, Safety & Environmental, HR, Supply Chain Physical Demands The characteristics hereby described are representative of those found while performing the essential duties of this job. Reasonable accommodation may be applied in order to allow disabled individuals to perform the essential functions effectively. Incumbent must have the ability to utilize tools to adjust and/or calibrate equipment. It is necessary to have vast process knowledge to train operators on their operators on their specific tasks. Body position will require being stand for long periods of time, climb stairs, and be seated. On occasions, physical effort is required to move raw materials. Working Environment The characteristics hereby described are representative of those found while performing the essential duties of this job. Reasonable accommodation may be applied in order to allow disabled individuals to perform the essential functions effectively. This job may require stagger shift 8 hrs, 7 days/wk. Production office area (mainly). Plant processing area (slightly, depending upon job requirements). Due to business nature, the incumbent must be able to dress special clothing, wearing safety boots and hard-hat without discomfort. The incumbent of this position will be exposed to different ambient and working condition. Must be able to work in outdoor and indoor. Will be expose to high level of noise, dust, and chemical reactive in different levels of humidity and temperatures using the required safety equipment. Must be capable to bear and use the required safety equipment for specific jobs or conditions including air mask (positive pressure, on demand or self-contained). 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 Our Culture: Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings. Posted by StartWire
Ciudad: barceloneta
