Boehringer Ingelheim Senior Specialist, Filling in ATHENS, Georgia

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.

Description:

The Supervisor will demonstrate a high level of competency and knowhow related to all aspects of filling, lyophilization, and capping. The incumbent will be responsible for direct supervision of one or more aseptic filling lines. Typically this will involve up to 12 operators per line.

The supervisor will guide production activities and technicians to insure production activities are efficient, accurate, compliant, and the associated operators have the skill levels that match the related work. Supervisors are highly knowledgeable in USDA regulations and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. The manufacturing supervisor will conduct themselves with honor and integrity as demanded by the nature of regulated vaccine production. In addition, this position is responsible for leading the manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives.

The Manufacturing Supervisors in coordination with the manufacturing schedule for the production facility, and contributes to the formulation of annual facility objectives. In meeting these goals, the supervisor will ensure the facility and equipment is maintained in a compliant state and ready for use. This person plays a significant role in unifying the manufacturing and quality groups.

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:

  • Requires a high level of documentation, investigative writing, production planning, and labor utilization skills.

  • Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.

  • Prepare daily/weekly production schedule, batch documentation and allocate the appropriate resources to the production teams

  • Ensure production schedule and complete associated documentation in compliance with regulatory requirements

  • Ensure raw materials are available and inventory accuracy is maintained

  • Reviews batch record documentation for accuracy and compliance in a timely manner; completes yield transactions or component returns.

  • Understands & adheres to good documentation practices (GDP)

  • Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.

  • Obtains knowledge and executes assignments in Quality areas: deviation management and/or change control.

  • Conducts investigations for cause, determines corrective action, and impact; writes reports & assures timely closure.

  • Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.

  • Oversee training and qualification of team members

  • Ensure equipment and facilities are properly maintained

  • Perform documentation reviews and revisions to all process documentation

  • Conduct annual employee performance reviews and assign individual goals/objectives

  • Monitor team performance through Key Process Indicators

  • Analyze key improvement opportunities and implement selected new ideas

  • Manage departmental expenses to ensure budget adherence

  • Escalate issues related to personnel, process and products to the appropriate leaders

  • Initiate/facilitate root cause analysis and implement corrective and preventative actions to address problems

  • Be proficient in departmental process activities

  • Demonstrate a visible & tangible commitment to HSE, Lean Principles, and the BI Values in all work related activities

  • In addition to the above, other assigned duties & projects deemed appropriate within the position scope

  • Ensures people and processes comply with Good Manufacturing Practices and company procedures.

  • Initiates, and/or reviews department standard operating procedures to support business and quality objectives.

  • Establishes & maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives

  • In addition to the above, other assigned duties & projects deemed appropriate within the position scope

Desired Skills, Experience and Abilities:

  • High school Diploma or equivalent plus minimum 6 years’ experience in related field

  • Demonstrated leadership skills- Coaching/Training

  • Work effectively in a team environment

  • Results oriented and ability to meet firm deadlines while working in a complex and variable environment

  • Require knowledge of the current GMPs and USDA requirements

  • Basic math skills

  • Equipment/Automation trouble shooting skills

  • Clean room and aseptic technique knowledge

  • Basic understanding of Lean Manufacturing principles

  • Proficient with Microsoft Office software and other database software

  • Excellent oral and written communication skills Preferred:

  • B.S. Biology or related field plus 3 years’ experience in related field

  • Strong organizational, time management, and project management skills, with exceptional attention to detail

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.

Organization: US-Merial, Inc.

Title: Senior Specialist, Filling

Location: Americas-US-GA-Athens

Requisition ID: 1814368