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JO-4290

Quality Search -  Since 1981

Position Title

Senior Packaging Engineer II

Location

Bay Area, California

Experience

8 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 II will function within the Device Development and Clinical Packaging Engineering (DDCPE) organization, which develops primary, secondary, and tertiary package and drug delivery device solutions that meet the needs of company’s pharmaceutical and biologics pipeline.  This position will have responsibilities in the areas of:

  • Controlled Temperature Shipping Containers
  • Primary and Secondary Package Development

Essential Functions:

·        Deliver technical leadership in the area of temperature controlled shipping containers, identifying solutions to meet stakeholder needs, partnering with suppliers to design solutions, and executing qualification studies and authoring related reports.

·        Partner with stakeholders to establish infrastructure necessary to bring shipping container solutions into service.

·        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 packaging components (e.g., bottles, blisters, vials, prefilled syringes, caps, stoppers).

·        Write and review SOPs related to DDCPE activities, ensuring alignment with other Company SOPs.

·        Design and write packaging study protocols and reports that support product development and regulatory filing needs.

·        Write sections of global regulatory filings related to DDCPE activities.

·        Train new employees in SOPs and documentation systems.


QUALIFICATIONS:  Requires a Bachelor’s Degree in Packaging, industrial, mechanical engineering, biomedical engineering or chemical engineering or a related scientific field.


Experience:  A minimum of eight (8) years of relevant experience is required, OR a Master’s Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of six (6) years of relevant experience.


Knowledge. Experience and Skills:

  • Knowledge of Temperature-Controlled Shipping Containers (Cold Chain). - Very important
  • Experience with (Primary and Secondary Package Development) - Very important
  • Excellent technical skills and knowledge of package development principles.
  • Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories is desirable.
  • Detailed understanding of the qualification process.
  • Knowledge of FDA and cGMP standards.
  • Strong verbal, written, and interpersonal communication skills.
  • Strong computer and organizational skills.

Preferred:

  • Prior experience in a cGMP-related industry is highly desirable.
  • Specific experience in the biotechnology sector is preferred.
  • Some overnight travel may be required up to 25% of the time.

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-4290

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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