A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market.
ESSENTIAL FUNCTIONS
* Serves as the primary packaging SME for assigned tech transfer and product development projects
across OSD and sterile/aseptic platforms; Interacts with project managers, clients and cross
functional teams throughout the project lifecycle.
* Supports overall site performance measures involving packaging materials and packaging
opportunities.
* Chairs bi-weekly meeting to ensure that client service, planning, and quality are aligned as to
upcoming changes and modifications.
* Heavy Communication directly with client counterparts and client documentation centers.
* Plans, directs and documents activities related to the design, development, and qualification of
primary, secondary and tertiary packaging systems including container closure systems (CCS) for
both solid oral and sterile injectable dosage forms.
* Evaluates component drawings, specifications and technical data packages to determine
appropriateness for intended use. Assesses compatibility with product, process, and regulatory
requirements.
* Works with clients, packaging component suppliers and site procurement to identify, source and
qualify appropriate containers and container closure systems.
* Provides technical input and oversight for packaging materials procurement supporting PD,
clinical, and commercial projects; partners with procurement to manage lead times, change
controls, and component availability.
* Leads the identification and qualification of appropriate primary and secondary labeling and
printed components; ensures compliance with label control procedures and applicable regulatory
requirements.
Works with packaging department management and mechanics during packaging component
selection process and works with Validation and QA groups during packaging component
qualifications.
* Authors, reviews, and approves packaging validation protocols and reports. Works with packaging
department management and mechanics during packaging line trials.
* For sterile packaging: Supports primary packaging development and qualification for vials,
prefilled syringes, cartridges, stoppers, crimp seals, and tub/nest configurations; applies
knowledge of container closure integrity (CCI) testing methodologies and ISO 11607/USP <1207>
standards.
* Supports regulatory submission activities including ANDA/NDA CMC packaging sections, design
history files (DHF), and responses to agency queries related to packaging and container closure
systems.
Pay is $45.00 - $50.00/hr
POSITION QUALIFICATIONS
* Strong technical writing skills with demonstrated ability to author and approve validation
protocols, SOPs, specifications, and regulatory documentation.
* Strong with Serialization and Aggregation Packaging process and selected systems like Optel,
Tracelink, Client Serialization Repository
* Current on trends in pharmaceutical packaging industry in terms of materials, equipment, and
regulatory requirements
* *May be required to wear personal protective equipment
* *May be required to move about the facility
* *May be required to remain sedentary for extended periods of time
EDUCATION:
Must have a Degree in Packaging Engineering or similar preferred
EXPERIENCE:
Must have Pharmaceutical Drug Manufacturing and Packaging experience
* Serialization and Aggregation Packaging Experience preferred.
Must have been a Packaging Engineer currently or in past.
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Synerfac Technical Staffing