Senior Validation Engineer

Sr. Validation Engineer

Clinton, TN | Full-time

At least one year of experience in a Pharmaceutical GMP setting is required for consideration.

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve.

In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle.

This role 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 Specialist 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.

• 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.

• 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.

• 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.

• 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…