Quality Search - Since 1981
Packaging Development Engineer II
3 or more years
B.S. Degree in Packaging or equivalent
Packaging Development Manager
with a Lump Sum
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
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
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.
with outside packaging material, equipment and testing suppliers to drive component selection and to coordinate
- 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.
and/or supports investigations, evaluates customer complaints and completes assigned corrective and preventative
- Supports factory acceptance testing (FAT) on new packaging equipment, as needed.
- Working with Packaging Equipment Engineers, conducts research on, identifies and recommends packaging
- Works with suppliers on the development of new packaging components.
- Works with the Packaging Development Manager to develop annual budget for assigned products and
- Compiles quotes and develops business case in support of Capital Expenditure
- 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.
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.
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 -
Quality Search, 1820 Graham Drive • Chesterton • IN • 46304-1627 • (219) 926-5015
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