Sr. Validations Specialist

Alcami Corporation•Morrisville, NC

13d•Onsite

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. Are you interested in joining our team? Job Summary The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate will work on extremely complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 4:00pm.

Requirements

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.
Basic knowledge of Kaye AVS.
Good understanding of and ability to utilize Pro Cal.
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.

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.