Sr. Validation Engineer - Packaging
About The Position
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. The Sr. Validation Engineer - Packaging is responsible for leading validation and qualification activities that support compliant pharmaceutical packaging operations, including packaging equipment, utilities, facilities, and computerized systems. The Sr. Validation Engineer - Packaging develops and executes validation protocols, maintains validation documentation, manages change controls, and ensures systems remain inspection-ready and compliant with cGMP, data integrity, and 21 CFR Part 11 requirements. The position partners closely with engineering, quality, operations, IT, contractors, and equipment vendors to support the installation, qualification, and ongoing performance of packaging-related equipment and systems. Additionally, the role serves as a validation subject matter expert during audits, provides technical guidance, authors SOPs and validation plans, and helps drive continuous compliance across packaging and operational processes.
Requirements
- Bachelor's degree in Engineering, Chemistry, Biology, or related field is required.
- At least one year of experience in a Pharmaceutical cGMP Manufacturing setting is required.
- Minimum 10 years of experience in a regulated manufacturing environment, preferably pharmaceutical, biotech, medical device, or consumer healthcare packaging.
- Experience qualifying and validating equipment, utilities, and computerized systems within a cGMP-regulated pharmaceutical, biotech, medical device, or packaging environment.
- Proven ability to lead validation projects, support new equipment implementation, manage change controls, and maintain systems in a validated state throughout their lifecycle.
- Strong analytical skills with the ability to work effectively across Engineering, Quality, Operations, IT, and external vendors to resolve complex technical and compliance challenges.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required.
- Strong technical, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
- Excellent communication, presentation, and stakeholder management skills with the ability to collaborate effectively across all levels of the organization.
Nice To Haves
- experience with project management and scheduling tools preferred.
Responsibilities
- Partner with Engineering, Operations, Quality, IT, vendors, and contractors on qualification and validation initiatives.
- Support the planning, installation, startup, and validation of new or updated equipment and systems.
- Serve as the primary validation resource for contractors and external service providers.
- Analyze complex technical and compliance issues and recommend effective solutions.
- Develop validation procedures, protocols, and project plans to support business and compliance objectives.
- Maintain qualification and validation documentation, ensuring accuracy, completeness, and audit readiness.
- Author and revise SOPs and Master Validation Plans (MVPs).
- Manage ongoing validation lifecycle activities, including change controls and periodic system reviews.
- Ensure validation activities are conducted in accordance with cGMP requirements and internal quality standards.
- Exercise technical judgment to resolve validation and compliance-related challenges.
- Act as a certified trainer and support validation-related training programs.
- Provide subject matter expertise on validation practices, compliance requirements, and system qualification strategies.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
