Job Description

- Project Validation Specialist III (Packaging)

Position Summary:

The Project Validation Specialist III - Packaging is responsible for leading validation activities related to packaging equipment, processes, and components within a regulated manufacturing environment. This role ensures that all packaging systems and processes meet applicable FDA, GMP, and corporate quality standards, supporting new product introductions, process improvements, and compliance initiatives.

Key Responsibilities:

Lead and execute validation activities for

packaging equipment, systems, and processes

, including IQ, OQ, and PQ protocols. Author, review, and approve

validation documentation

, such as validation master plans (VMP), protocols, reports, and risk assessments. Coordinate

commissioning and qualification (C&Q)

activities for new or modified packaging equipment. Collaborate with Engineering, Manufacturing, Quality Assurance, and Packaging Development to ensure validation deliverables align with project timelines and regulatory requirements. Perform and document

change control assessments

, deviations, and CAPAs related to packaging validation activities. Evaluate and qualify

packaging components

(bottles, caps, seals, labeling materials, etc.) to ensure compliance with functional and regulatory specifications. Provide technical support for troubleshooting packaging processes and equipment performance issues. Ensure all validation activities comply with

FDA, EU, and ISO 13485

guidelines, and internal corporate procedures. Participate in internal and external

audits

, providing validation evidence and supporting documentation as required.

Qualifications & Experience:

Bachelor's degree in

Engineering, or related field

. Minimum

5-8 years of experience

in validation within a

pharmaceutical or medical device

manufacturing environment. Demonstrated expertise in

packaging components and equipment

, including filling, labeling, sealing, and inspection systems. Strong understanding of

cGMP, FDA, ISO 13485, and GAMP 5

standards. Proficiency in

technical writing

, protocol execution, and validation report generation. Experience with

risk management, equipment qualification, and process validation

methodologies. Excellent analytical, problem-solving, and cross-functional collaboration skills.

Preferred Skills:

Experience with

automated packaging lines

, serialization systems, and vision inspection equipment. Familiarity with

SAP, TrackWise, or electronic validation management systems

. Fully Bilingual
Job Type: Full-time

Pay: $30.00 - $45.00 per hour

Expected hours: 40 per week

Application Question(s):

Can you describe your hands-on experience with packaging validation activities, including qualification of packaging equipment (such as fillers, cappers, labelers, and sealers) and validation of packaging components or processes in an FDA-regulated environment? Please include specific examples of the type of equipment, protocols (IQ/OQ/PQ), and systems you have worked with.
Education:

Bachelor's (Preferred)
Experience:

Concept validation: 5 years (Required)
Shift availability:

Day Shift (Required)
Work Location: In person