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JO-4307

Quality Search -  Since 1981

Position Title

Senior Packaging Engineer I

Location

Bay Area, California

Experience

5-7 or more years

Specialty

Bio-Pharmaceuticals

Salary Range

Competitive                 

Targeted Bonus Range

Competitive

Education

B.S. Degree in Packaging Engineering or equivalent

Travel

Up to 25%

Reports to

Director of Engineering

Relocation

Yes, for the right candidate. (Lump Sum)

COMPANY – DUTIES – QUALIFICATIONS

COMPANY:  This company is a research-based Bio-pharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Its goal is to transform and simplify care for people with life-threatening illnesses around the world. Their therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. They have over 10,000 employees and are one of the leading companies in their field.


DUTIES:  The Senior Packaging Engineer I will focus on the development of primary, secondary, and tertiary packaging solutions and support of clinical manufacturing operations for oral solid dosage and parenteral products. They are seeking a motivated, detail oriented individual able to deliver technical leadership in a cross-functional team setting.


Specific Job Responsibilities:

  • Deliver technical leadership in the area of package development and manufacturing operations, identifying
  • solutions to meet stakeholder needs, partnering with suppliers and contract manufacturing organizations (CMOs), and driving product development.
  • Lead packaging activities in support of multiple clinical programs in all phases of development through commercialization.
  • Perform characterization and qualification of primary packaging components (e.g., bottles, blisters, vials, prefilled syringe systems).
  • Support packaging operations and lead technical aspects of product quality investigations related to packaging.
  • Design and author packaging study protocols and reports on topics such as packaging equipment and process qualifications, shipping studies, label testing, USP testing, child resistance/senior friendly testing, etc.
  • Author global regulatory content pertinent to packaging.
  • Effectively communicate ideas, project goals, and results to team members across functions and departments.

QUALIFICATIONS:  

Requires a B.S. Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 5-7 or more years of relevant industry experience required.  A Master’s Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of five (5) years of relevant industry experience required.  Advanced degree(s) with commensurate industry experience are also considered.  Prior experience in a cGMP-related industry is highly desirable.


Additional Experience:

  • Experience with development and commercialization of packaging for pharmaceutical products.
  • Working knowledge of FDA and cGMP standards for pharmaceutical packaging.
  • Experience with parenteral product components and manufacturing.
  • Experience working with pharmaceutical contract manufacturing organizations (CMOs).
  • Self-motivated and organized, knowledgeable of relevant scientific literature,
  • Passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.

Knowledge & Skills:

  • Strong verbal, written, and interpersonal communication skills.
  • Must be able to write clear, concise, and error-free documents.
  • Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.

To inquire or further discuss, call Jeff Wolfe  219-926-5015 (Talk/Text), or Inquire by email to Jeff Wolfe

Not interested, then please Pass this job along to a fellow Packaging Professional

Quality Search, 1820 Graham Drive • Chesterton, IN 46304-1627 • (219) 926-5015 www.qsjobs.com

We promise never to share your information with anyone without your prior consent.

Must be a United States citizen or lawful permanent resident or have authorization to work in the United States.

 



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