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JO-4295

Quality Search -  Since 1981

Position Title

Senior Packaging Engineer I

Location

Bay Area, California

Experience

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 work in the Device Development and Clinical Packaging Engineering (DDCPE) organization, which provides technical leadership and expertise in the development, qualification, and implementation of new primary, secondary, and tertiary package and drug delivery device solutions that meet the needs of Gilead’s pharmaceutical and biologics pipeline. The selected candidate will work on a variety of packaging initiatives and will lead the development and qualification of global packaging solutions of assigned projects.  This activity involves collaboration with Product Development Teams, Regulatory, CMO’s, Quality, Suppliers and other involved stakeholders.


Specific Job Requirements:

  • Deliver expertise in the application of pharmaceutical packaging principles and testing methodologies related to container closure systems.
  • Develop innovative, thorough, and practicable solutions to a wide range of difficult packaging problems.
  • Lead packaging activities in support of multiple clinical programs in all phases of development, ensuring on-time delivery of project deliverables and compliance to current Good Manufacturing Practice (cGMP).
  • Execute packaging equipment and process verification and validation (including IQ/OQ/PQ studies) to prove effectiveness of new packaging configurations and/or packaging lines/sites.
  • Support packaging operations and drive expeditious and appropriate resolution of deviations and investigations as necessary.
  • Perform characterization and qualification of primary and secondary packaging components (e.g., bottles, blisters, vials, , caps, stoppers, labels, and britestock shippers).
  • Design and write packaging study protocols and reports that support product development and regulatory filing needs.
  • Ensure compliance with international and external regulations.
  • Write sections of global regulatory filings related to DDCPE activities.
  • Write and review SOPs related to DDCPE activities, ensuring alignment with other Gilead SOPs.
  • Train new employees in SOPs and documentation systems.
  • Overnight travel may be required up to 25% of time.

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 seven (7) 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.


Knowledge and Skills:

  • Excellent technical skills and knowledge of package development principles is required.  Specific experience in the pharmaceutical/biotechnology sector is preferred.
  • Expertise in the application of pharmaceutical packaging standards (e.g., USP, ISO, ASTM).
  • Knowledge of FDA and cGMP standards is required.
  • Strong verbal, written, and interpersonal communication skills are required.
  • Strong computer and organizational skills are required.
  • Experience collaborating with external suppliers, contract manufacturing organizations, and contract test laboratories is desirable.
  • Ability to travel up to 25% some overnight.

Contact us to discuss this opportunity - OR -  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.

 

For further details on JO-4295

Inquire through Tony Vesh

Ph:  (219) 926-6831     Bio of Tony Vesh

Inquire through Doug Scripture

Ph:  (269) 598-1915     Bio of Doug Scripture

Inquire through Jeff Wolfe

Ph:  (219) 926-5015     Bio of Jeff Wolfe

- OR -

 

Inquire through Quality Search

A Recruiter will be assigned to you.

Ph:  (219) 926-7772     Web Site   

We look forward to working with and for you in your career enhancement!

 



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