JO-4211

Quality Search  -  Since 1981

Position Title:

Packaging Development Engineer II

Location:

Rocky Mountains

Experience:

3 or more years

Specialty:

Pharmaceuticals

Salary Range:

$75-98K  C-E

Bonus Range:

5%

Education:

B.S. Degree in Packaging or equivalent

Travel:

5%

Reports to:

Packaging Development Manager

Direct Reports:

None

Relocation:

Assistance available with a Lump Sum

Other:

They would like a person with pharmaceutical experience. In particular, experience that includes Bottles, Closures, Jars, Tubes, Vials, Syringes and Pumps. Of these the Syringe experience is the most important.

DESCRIPTION - DUTIES

Company Overview:  This company is a pharmaceutical research, development, manufacturing and commercial operations company. It develops and manufactures both proprietary and generic pharmaceutical products. It has additional products that fall under the category of parenterals (injectables) more aligned with medical devices. Yet another focus is in dermatology, oncology, and specialty injectable therapeutic areas.


Position:  The Packaging Development Engineer II, under limited supervision, will develop the packaging components and packaging requirements for existing commercial products and for development projects.  He or she will develops, maintains and monitors packaging components to ensure compliance with Quality, Safety, Manufacturing and Regulatory guidelines and procedures. In addition, they will conduct testing activities that influence selection of primary, secondary and tertiary packaging components. 


Essential Duties & Responsibilities:

  • Demonstrates sound and effective technical development and evaluation skills for packaging components, equipment and processes.  
  • Works with project team to identify, select, and test primary, secondary and tertiary packaging components.
  • Interacts with outside packaging material, equipment and testing suppliers to drive component selection and to coordinate testing services.
  • Determines component availability, unit costs and lead times from primary and secondary suppliers, as applicable. 
  • Serves as the main point of contact for project related component suppliers and testing facilities.
  • Authors, edits and reviews Standard Operating Procedures and Work Instructions for pertinent packaging equipment and processes.
  • Identifies and develops packaging related testing and verification assessments to include shipping studies, dimensional measurements, container integrity and USP compliance, materials of composition identification and sterility compatibility in support of packaging component development.
  • Authors and edits manufacturing batch records related to packaging processes.
  • Develops packaging procedures and trains Operations personnel on packaging equipment and processes.
  • Authors and successfully executes qualification protocols and reports on all assigned packaging equipment and processes.
  • Conducts and/or supports investigations, evaluates customer complaints and completes assigned corrective and preventative actions (CAPA).
  • Supports factory acceptance testing (FAT) on new packaging equipment, as needed.
  • Working with Packaging Equipment Engineers, conducts research on, identifies and recommends packaging equipment.
  • Works with suppliers on the development of new packaging components.
  • Works with the Packaging Development Manager to develop annual budget for assigned products and projects.
  • Compiles quotes and develops business case in support of Capital Expenditure Approvals (CEA).
  • Completes Purchase Requisitions and Inventory Requisitions required for assigned products and projects.  
  • Identifies cost saving opportunities and prepares detailed cost savings proposals for presentation to Senior Management. 
  • Drives and executes Quality Improvement initiatives related to packaging components and processes.
  • Drafts comprehensive qualification protocols and reports supporting packaging component and packaging process qualifications (URS, DQ, IQ/OQ, and PQ). 
  • Provides support to Senior Packaging Development Engineers and oversees junior Packaging Development Engineers.
  • Complies with company procedures and processes.
  • Supports Quality department audits, e.g., external suppliers, as necessary. 
  • Completes special projects and other duties as assigned.

REQUIREMENTS - BACKGROUND

Education:  Requires a Bachelor's degree in Packaging Engineering or related equivalent technical field.


Experience:  Requires a minimum of 3 or more years experience working with primary, secondary, and tertiary packaging materials, equipment, vendors, and regulations, specifically those used in the pharmaceutical, medical device or health care industry.  Understanding of the requirements (GMP, Validation, CFR, etc.) applicable to working within a regulated industry.


Knowledge, Skills & Abilities:

  • Working knowledge of various logistical impacts, i.e., palletization, cold chain management and serialization of packaging components.
  • Working knowledge of packaging equipment and packaging component suppliers.
  • Experience in leading a cross-functional team.
  • Self-motivated and works effectively both independently and in a team setting.
  • Working knowledge of various Primary packaging systems: Bottles, Closures, Jars, Tubes (Aluminum, Laminate), Vials, Syringes, and Pumps specifically those used in the pharmaceutical, medical device or health care industry. 
  • Working knowledge of various Secondary packaging systems: Labels, Cartons, Inserts, Tray Packs, and Pouches specifically those used in the pharmaceutical, medical device or health care industry.
  • Working knowledge of various Tertiary packaging systems: Shippers specifically those used in the pharmaceutical, medical device or health care industry
  • Knowledge of FDA guidelines and cGMP Procedures.
  • Excellent documentation practice and technical writing skills.
  • Ability to handle and effectively manage multiple projects; of both low and high priority simultaneously.
  • Must be able to work in a fast-paced, changing work environment, possess good time management skills, and exhibit personal responsibility.
  • Positive attitude and willingness to perform labor-intensive work when necessary.

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 (HQ) www.qsjobs.com

 

For further details on JO-4211

Inquire through Tony Vesh

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

Inquire through Peter Nye

Ph:  (219) 851-7478     Bio of Peter Nye

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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