Boehringer Ingelheim · 1 day ago
Principal Specialist, Packaging Training & Compliance
Athens, GA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expBoehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to improving lives through innovative healthcare solutions. The Principal Specialist, Packaging Training & Compliance will lead the documentation team to ensure compliance with regulatory requirements and develop training programs for personnel in the Packaging department.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Acts as PKG internal SME for routine production issues leading towards deviations, product dispositions, and response corrections needed to continue production
Works directly with upstream and downstream processes to ensure all documentation and trending issues impacting PKG Department are addressed to mitigate production downtime
Works directly with PKG Team Leaders to ensure all shifts are working in compliance with Packaging guidelines/specifications
Supervises the timely execution and completion of CAPAs, Investigations, Deviations, TPC, & Change Controls assigned to PKG Leadership
Works with Packaging Management to properly document any additional training outside of the LOS including On The Job (OJT) Training and sign-off to ensure successful ownership of training material
Performs all Company business in accordance with all regulations (e.g., EEO, USDA, EU, EMA etc.) and Company policies and procedures
Immediately reports noted/observed violations to management
Leads alignment of release functions across different areas within production and maintains/develops PKG Training Program
Interfaces with site management, Regulatory Affairs, production area managers and supervisors to ensure release and support functions are consistent and within regulatory requirements
Responsible for maintaining the training of PKG personnel to meet regulatory requirements
Position directly impacts the production process and the ability to get product produced RFT (right the first time)
Directly supervises up to 2 direct reports
Responsible for ensuring compliance of all documentation
Leads PKG document specialist through daily operations
Conducts or assists with performance evaluations and development discussions
Leads a team of QA professionals through daily operations
As requested by the manager conducts or assist with performance evaluations and development discussions
Oversees the review / approval of manufacturing records, deviations, product holds / dispositions, change controls, CAPAs, document creation / revision, etc. as needed to release product according to applicable procedures
Qualification
Required
Bachelor's degree, from an accredited institution, in a relevant scientific discipline
In addition to Bachelor's degree, minimum five (5) years related experience and/or training in a Manufacturing environment in Quality Assurance, Quality Control, Sterility Assurance, Engineering, Production, or Qualification / Validation
Ten (10) years relevant experience in lieu of degree
Must have appropriate knowledge and good understanding of quality activities related to pharmaceutical manufacturing process; examples include product release, batch record review, root cause analysis, change control
Must have appropriate knowledge and good understanding of training activities related to pharmaceutical manufacturing process
Functional knowledge of product manufacturing activities is required
Functional knowledge of USDA requirements for biologic production is recommended
Demonstrated high ethical and professional standards with all business contacts to maintain BIAH excellent reputation in the community
Preferred
Experience must be inclusive of three (3) years leadership experience
Experience with Packaging, Labeling, bioreactors, parenteral filling lines, freeze dryers
Experience with licensed biopharmaceutical or biological products
Experience with aspects of sterility assurance (i.e., environmental monitoring, aseptic process simulations or media fills, water systems, aseptic technique, etc.)
Experience in an FDA and/or USDA or other regulated industry
Fully versed in GMP's, FDA, USDA, European and other regulatory agency requirements sufficient to comply to quality operations and compliance
Training and experience in root cause analysis tools
Computer skills in Microsoft Office applications and the ability to learn new applications quickly and easily
Benefits
Competitive compensation and benefit programs
Programs and groups that ensure your health and wellbeing are looked after
Company
Boehringer Ingelheim
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 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10001+ employees
H1B Sponsorship
Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (4)
2023 (11)
2022 (7)
2021 (17)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
Corp. SVP BioPharma Network
Clemens Twardy
Corporate Vice President, Head of Global Supply Chain and Lifecycle Management Animal Health
Recent News
BioWorld Financial Watch
2026-02-02
Mexico Business
2026-02-02
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