Sr. Pharmaceutical Packaging Engineer

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada. Our family of companies offers complete CDMO services including custom synthesis of intermediates,reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!

OVERVIEW

The Sr. Packaging Engineer is a key technical leader within the Pharmaceutical Packaging Department,responsible for driving the successful implementation of new products, technology transfers, and associated packaging activities across both Oral Solid Dosage (OSD) and sterile/aseptic dosage forms. This role serves as the primary packaging subject matter expert (SME) for client-facing projects, equipment qualification, component development, regulatory compliance, and the continued advancement of Halo Pharma's packaging capabilities—including support of the upcoming sterile injectable manufacturing line. 100% onsite position at 30 N. Jefferson Rd, Whippany, NJ

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. Provides packaging technical support for aseptic fill-finish operations, including component preparation, filling, stoppering, sealing, visual inspection, and labeling processes in classified cleanroom environments. Writes, reviews, and approves packaging component specifications, batch record packaging sections, and department SOPs; supervises technical writers responsible for the generation of and revisions to packaging specifications. Works with department management and mechanics in identification and selection of new packaging department equipment and works with Engineering, Validation and QA during equipment qualifications. Supports packaging by troubleshooting or working to resolve packaging component issues. Serves as site representative with/ for serialization and aggregation activities; schedules and conducts vendor meetings, manages Optel and Tracelink system interactions, and coordinates with the Client Serialization Repository to ensure compliance with DSCSA requirements. 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. Champions continuous improvement initiatives within the Packaging Department, identifying opportunities to improve line efficiency, reducing waste, and enhancing packaging quality outcomes. Other duties as assigned.

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

Degree in Packaging Engineering or similar preferred

EXPERIENCE

Pharmaceutical Drug Manufacturing and Packaging experience Serialization and Aggregation Packaging Experience preferred. Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Job Types:

Full-time, Temporary Pay:

$50.00 per hour

Work Location:

In person Sr. Pharmaceutical Packaging Engineer 30 North Jefferson Road, Whippany, NJ 07981 $50 an hour - Temporary, Full-time $50 an hour - Temporary, Full-time

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada. Our family of companies offers complete CDMO services including custom synthesis of intermediates,reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!

OVERVIEW

The Sr. Packaging Engineer is a key technical leader within the Pharmaceutical Packaging Department,responsible for driving the successful implementation of new products, technology transfers, and associated packaging activities across both Oral Solid Dosage (OSD) and sterile/aseptic dosage forms. This role serves as the primary packaging subject matter expert (SME) for client-facing projects, equipment qualification, component development, regulatory compliance, and the continued advancement of Halo Pharma's packaging capabilities—including support of the upcoming sterile injectable manufacturing line. 100% onsite position at 30 N. Jefferson Rd, Whippany, NJ

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

standards. Provides packaging technical support for aseptic fill-finish operations, including component preparation, filling, stoppering, sealing, visual inspection, and labeling processes in classified cleanroom environments. Writes, reviews, and approves packaging component specifications, batch record packaging sections, and department SOPs; supervises technical writers responsible for the generation of and revisions to packaging specifications. Works with department management and mechanics in identification and selection of new packaging department equipment and works with Engineering, Validation and QA during equipment qualifications. Supports packaging by troubleshooting or working to resolve packaging component issues. Serves as site representative with/ for serialization and aggregation activities; schedules and conducts vendor meetings, manages Optel and Tracelink system interactions, and coordinates with the Client Serialization Repository to ensure compliance with DSCSA requirements. 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. Champions continuous improvement initiatives within the Packaging Department, identifying opportunities to improve line efficiency, reducing waste, and enhancing packaging quality outcomes. Other duties as assigned.

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

Degree in Packaging Engineering or similar preferred

EXPERIENCE

Pharmaceutical Drug Manufacturing and Packaging experience Serialization and Aggregation Packaging Experience preferred. Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Job Types:

Full-time, Temporary Pay:

$50.00 per hour

Work Location:

In person