Description

　　The Principal Specialist, Packaging Training & Compliance will lead the Packaging (PKG) documentation team to support the production line as required through batch documentation review, deviations, change controls, CAPAs, and document creation / revision in compliance with procedures and regulatory requirements.This role develops, reviews, and maintains an up-to-date training program to meet all compliance requirements and packaging requirements. The incumbent will maintain supplemental training records and ensures all personnel are up to date on all compliance requirements. Primary means of tracking training will be through LOS System. On the Job Training (OJT) will tracked separately outside of LOS. This role implements effective CAPAs to mitigate potential issues in deviations and audits.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 several 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

　　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.

　　Supervisor areas:

　　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.

　　Product Release:

　　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.Requirements

　　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.

　　Desired Skills, Experience and Abilities

　　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.