Alcami Corporation · 4 days ago
Sr. Validations Specialist
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines. The Sr. Validations Specialist is responsible for driving results in pharmaceutical validation of equipment and computerized systems, ensuring compliance with regulatory standards, and serving as a subject matter expert during audits and inspections.
Pharmaceuticals
Responsibilities
Performs the qualification and validation of production equipment, utilities, and computer systems
Assists in equipment selection and specification
Works on complex problems of broad scope in which analysis of situation or data requires a review of identifiable factors
Exercises judgment within defined procedures and practices to determine appropriate action
Maintains all documentation pertaining to qualification and validation
Develops procedures, protocols, and validation project plans
Serves as Validations resource for contractors and vendors
Executes procedures and protocols
Maintain the compliance of validated systems through on-going validation activities (e.g., change control, periodic system reviews, etc.)
Composes/revises SOP’s and master validation plans
Collaborate with cross-functional teams to assist in the planning, development, installation, operation, validation, and qualification of newly installed or updated equipment and/or computerized systems
Strong knowledge and experience with facility, utility, instrument, and equipment qualifications
Ensures completion & compliance with cGMP and all other relevant company training requirements
Acts as a certified trainer
Provide qualification guidance to IT for infrastructure and computerized system platforms
Other duties as assigned
Qualification
Required
Bachelor's Degree in Engineering, Chemistry, Biology, or related field required
5+ years of related experience required
Excellent knowledge of quality assurance reviews of validations documentation
cGMP training and basic understanding
Excellent knowledge of pharmaceutical GMP environment
Strong communication skills (oral and written)
Strong mechanical skills
Strong working knowledge of Microsoft Office applications
Ability to work on multiple projects simultaneously, with strong attention to detail
Ability to train and mentor others
Preferred
Basic knowledge of Kaye AVS
Good understanding of and ability to utilize Pro Cal
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase