Senior Validation Engineer - Packaging

 

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.

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Job Summary

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.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.

Responsibilities

Validation & Qualification

• 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.

Validation Program Management

• 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.

Cross Functional Project Support

• 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.

Compliance, Training, & Technical Leadership

• 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.

Qualifications

• 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.
• Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.

Knowledge, Skills, and Abilities

• 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; experience with project management and scheduling tools preferred.
• 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.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly stand, walk, and use hands, frequently reach, stoop, kneel, crouch or crawl and talk or hear, and occasionally sit and climb or balance. In this role, the employee will frequently work in an office, lab or at customer sites and be exposed to extreme cold (non-weather). The employee will occasionally be exposed to wet or humid conditions, work near moving mechanical parts, work in high places, near toxic or caustic chemicals, in outdoor weather conditions and exposure to vibration. The noise level that is typical for this position is loud.