HomeAvailable PositionsAbout YouSUBMIT YOUR RESUMEAvailable ProfessionalsAbout UsContact UsSite MapResource LinksClientsFAQs By CandidatesFAQs By CompaniesSALARY RANGES - Through The Years For Packaging ProfessionalsTestimonials

JO-4279

Quality Search -  Since 1981           

Position Title

Senior Packaging Engineer

Primary Work Location

Bay Area, California

Experience

6 or more years

Specialty

Bio-Pharmaceuticals

Salary

Competitive

Bonus

15% (Target Potential)

Education

BS in Packaging Engineering or equivalent.

Travel

25%

Reports to

Director of R&D

Direct Reports

None

Other

This is an exciting opportunity to get in on the ground floor of an exciting and dynamic young company!

Relocation

Yes, for the right candidate. (Lump Sum)

DESCRIPTION - DUTIES

Company Overview:  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. It has over 10,000 employees and is one of leading companies in its field.


Position: This technical track position resides in the Commercial Packaging & Labeling organization at the company.  The Commercial packaging team is mainly responsible for supporting new product launches and market extensions, leading capital projects, supporting packaging projects at contract manufacturing organizations, managing packaging component suppliers and ensuring uninterrupted supply of commercial products to our patients.


Specific Job Requirements: 

·        Deliver technical leadership in the area of package engineering, identifying solutions to meet stakeholder needs, partnering with suppliers and contract manufacturing organizations (CMOs), and driving manufacturing solutions.

·        Support new product launches and market extension projects. 

·        Work collaboratively with multiple functional areas to meet complex project deliverables and ensure on-time delivery of project deliverables. 

·        Ensure product meets regulatory, performance, and cost requirements and maintain compliance to current Good Manufacturing Practices (cGMP).

·        Design, write, and execute packaging study protocols such as shipping qualifications, transportation studies, label adhesion, etc. and issue reports.

·        Interface with contract manufacturers in weekly meetings for projects and routine production.  Review and approve protocols, master batch records, reports, and relevant CMO documents.

·        Execute packaging equipment qualification and process validation (including IQ/OQ/PQ studies) to prove effectiveness of new packaging configurations and/or packaging lines.

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

·        Develop User Requirement Specifications for new packaging equipment and lines; request quotes from equipment manufacturers for assessment by Company Management.

·        Contributes to and may lead technical investigations and deviations to drive expeditious and appropriate resolution.

·        Support labeling changes at CMOs and Company sites.

·        With minimal guidance, determines the functions most critical to departmental success and supports priorities accordingly.

·        Review existing SOPs and author new SOPs as necessary, relevant to Commercial Packaging & Labeling processes.

·        Represent Commercial Packaging & Labeling in CMC sub-teams.

·        Train new employees in SOPs and documentation systems.

·        Overnight travel may be required up to 25% of time.

·        Lead departmental strategic initiatives. Contributes to and may lead complex processes across functions.

REQUIREMENTS - BACKGROUND

Education:  Requires a B.S. degree in Package Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related scientific field.


Experience:  A minimum of 6 years of relevant industry experience is required.  Advanced degree(s) with commensurate industry experience are also considered

·        Prior experience in a cGMP-related and regulated industry is highly desirable

·        Knowledge of the FDA regulations, USP and cGMPs is highly desirable


Knowledge:

·        Strong knowledge of packaging equipment such as tablet fillers, cappers, induction sealers, blister packaging equipment, bottle labelers, cartoners, etc.

·        Detailed understanding of equipment qualification and process validation is required.

·        Strong technical skills and knowledge of packaging components including primary, secondary and tertiary packaging.

·        Strong verbal, written, and interpersonal communication skills are required.

·        Strong computer, organizational, and project management skills required.

·        Experience collaborating with external suppliers, CMOs, or contract test laboratories is desirable.

Audit and Investigation Skills are desirable.

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 US citizen or lawful permanent resident or have authorization to work in the US w/o needing sponsorship.

 

 
 

For further details on JO-4279

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!



Follow us on:  
linkedin.jpg        twitter_logo_large.jpg

 "Our goal is to find the "Right" Position that Matches your Requirements!"