Serialization Manager Jobs in Monroeville, NJ (NOW HIRING)

Our Business
Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.
By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind "Transforming Drug Delivery - Transforming Lives."
Our Culture
When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.
In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.
Why Come to Adare?
Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare's investment in their growth.
We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.
Position
Senior Packaging Engineer
Location
Philadelphia, PA
Summary
The Senior Packaging Engineer is a key member of the Engineering team and is instrumental in executing project plans directly related to packaging. This includes ownership of technical performance, compliance, validation, troubleshooting, and lifecycle management of packaging and serialization systems while serving as the primary engineering resource for packaging process development, deviation investigations, root cause analysis, and serialization compliance.
In addition, the Engineer will establish packaging systems that meet the needs of Adare's customers with optimal process and cost effectiveness. The Packaging Engineer is expected to manage projects and provide expert leadership concerning packaging and packaging systems, and collaborate with internal teams such as Quality, Technical Services, and Manufacturing, as well as with Adare's external customers in reviewing projects, providing input on packaging proposals, and recommending creative packaging solutions.
Responsibilities

• Evaluate, recommend, develop, implement, and maintain packaging materials, packaging systems, and serialization solutions based on operational, regulatory, quality, customer, and business requirements.
• Serve as the site technical expert for packaging and serialization systems, including packaging equipment, vision inspection systems, printers, scanners, line controllers, aggregation equipment, and enterprise serialization interfaces.
• Lead packaging development activities for new product introductions, line extensions, market launches, customer transfers, and packaging component changes.
• Collaborate with customers, Quality, Manufacturing, Technical Services, Validation, Regulatory Affairs, IT, and suppliers to develop and implement packaging and serialization solutions.
• Develop, execute, and document packaging studies, engineering trials, protocols, and technical reports to support product development, process improvements, validations, and regulatory submissions.
• Support packaging component selection, equipment selection, technology assessments, and implementation activities for packaging and serialization systems.
• Troubleshoot packaging and serialization equipment, systems, and processes to resolve technical issues, minimize operational disruptions, and maintain regulatory compliance.
• Investigate packaging and serialization deviations, non-conformances, and quality events utilizing structured root cause analysis methodologies, including 5-Why, Fishbone, Fault Tree Analysis, and CAPA development.
• Lead technical investigations related to packaging defects, vision inspection failures, barcode quality issues, aggregation failures, data transmission errors, and serialization exceptions.
• Develop, establish, monitor, and continually improve Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and control strategies associated with packaging and serialization processes.
• Conduct risk assessments, impact assessments, and Failure Mode and Effects Analysis (FMEA) activities to support process changes, equipment modifications, and new product implementations.
• Support process validation, equipment qualification, computer system validation, and serialization system lifecycle management activities, including FAT, SAT, IQ, OQ, and PQ execution.
• Participate in manufacturing feasibility studies, scale-up activities, engineering batches, validation batches, batch record development, and technical report generation.
• Maintain compliance with applicable serialization and track-and-trace regulations, including DSCSA, EU FMD, and other applicable market requirements.
• Author, review, revise, and approve SOPs, work instructions, engineering standards, validation documentation, and technical specifications supporting packaging and serialization operations.
• Collaborate with internal and external stakeholders to assess, implement, and validate packaging component, equipment, software, and serialization system changes.
• Support customer audits, regulatory inspections, supplier assessments, and due diligence activities involving packaging and serialization systems.
• Lead or participate in cross-functional project teams to execute packaging, serialization, compliance, and technology-related initiatives.
• Provide technical mentorship and guidance to manufacturing, quality, validation, technical services, and engineering personnel regarding packaging and serialization systems.
• Drive continuous improvement initiatives focused on quality, compliance, reliability, process robustness, and risk reduction within packaging and serialization operations.
• Other duties as assigned

Experience, Education, and Skills Required

• Bachelors' degree in Engineering or related technical field and 6+ years' experience in Packaging Engineering in a GMP industry
• Working experience with serialization systems
• Experience performing root-case analysis and deviation investigations
• Blister packaging experience is a plus
• Packaging development related to: glass, plastics, delivery systems, sterilized components
• Project management capabilities
• Lean manufacturing skills
• General knowledge of solid oral dose processing is a plus

Physical Demands and Work Environment

• This is primarily an on-site role based at the Philadelphia packaging facility.
• Ability to walk the production floor, climb stairs, and stand for extended periods
• Ability to wear required personal protective equipment (PPE) and follow gowning procedures when entering packaging, manufacturing, laboratory, or warehouse areas, per site requirements.
• May be exposed to manufacturing, laboratory, or warehouse environments and must follow all site safety, GMP, and gowning protocols.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES
Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there's no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can't quickly verify the identity of the poster.