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Company

Original Job Post

Boehringer Ingelheim · 2 days ago

Principal Process Engineer, Lyophilization

Athens, GA

Full-time

Onsite

Senior Level

7+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

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Responsibilities

Develops Lyophilization process recipes, ensuring proper operation and reliability. Selects proper equipment for the operation of refrigerated storage

Ensures maintenance and reliability of the lyophilization and refrigeration equipment.

Responsible for the proper equipment operation and troubleshooting of Lyophilizers and refrigerated storage systems and effecting necessary repairs. Selects proper parts for alteration of equipment

Responsible for the preventive maintenance instructions for these equipment

Effectively utilizes statistical methods to monitor and understand process variation routinely and recommend appropriate action based on trends

Maintains departmental performance metrics ensuring clear visibility at the floor level, management level, and site level

Works with deviations occurring in the lyophilization and refrigeration areas, including root cause analysis, CAPA development, and CAPA implementation

Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Engineering and Purchasing to aid in effectively meeting site objectives

Demonstrates a visible and tangible commitment to EHS and the BI Values in all work-related activities

Qualification

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RefrigerationBiopharmaceutical regulations manufacturing practicesMicrosoft OfficeStatistical analysisSchedulingWillingness to take drug testProject activitiesCommunicationLeadershipProblem-solvingProject managementLyophilization Training

Required

BS in Engineering; BS in Biology or related field

Minimum of seven (7) years on the job experience in the refrigeration field

Demonstrated knowledge and understanding of biopharmaceutical regulations and good manufacturing practices and demonstrated ability to understand and work within a regulated environment

Excellent communication skills, both verbally and written

Ability to lead/manage effective meetings both within and outside of the department

Ability to communicate with a diverse population, including vendors, consultants, BIVI functions, etc

Fluency in Microsoft Office software

Statistical analysis experience

Demonstrated ability to apply analytical stills to identify problems, recognize symptoms, causes and provide alternative solutions

Effective project management skills planning, scheduling, organizing, prioritizing, and coordinating project activities

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

Preferred

Formal Lyophilization training is desired

Benefits

Competitive compensation

Benefit programs

Company

Boehringer Ingelheim

Glassdoor

4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10,001+ employees