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Job: Validations Specialist III, Alcami, Wilmington, NC

General Information

Job title:
Validations Specialist III
Job location:
Wilmington, NC  28405 United States
Requisition code:
Date posted:
Job category:
Employment type:
Full time

Job Description

Position Summary

The Validations Specialist III is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation activities. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, packaging, and manufacturing equipment; conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; monitoring compliance; developing documentation as required for projects; and consulting on validation and cGMP questions and issues. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.


Essential Functions

  • Oversee a wide range of activities assuring that systems, facilities and equipment at contract manufacturing organizations comply with accepted GMPs and regulatory expectations utilizing a life-cycle approach, risk management tools (such as FMEA) and principles

  • Performs the qualification (including re-qualification) and validation focused on manufacturing and packaging equipment, utilities, and facilities.  Monitors the progress against the timelines established for these events.  Although the focus will be on manufacturing equipment, qualification of laboratory instruments will also be in the scope of this position.

  • Authors and executes FAT, SAT, and commissioning protocols and like activities for manufacturing and utilities as needed.

  • Assists in equipment specification and selection, specification .

  • Maintains all documentation pertaining to qualification and validation.

  • Develops procedures and/or protocols.

  • Serves as information resource for validation technicians, contractors and vendors.

  • Executes procedures and/or protocols.

  • Reviews, composes/revises SOP’s and master validation plans.

  • maintain a validation event (i.e. re-qualification) scheduling/triggering program within the CMMS environment or other compliant arena. Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

  • Participates in GMP audits (client and regulatory)

  • Participates in the change control process for manufacturing equipment, utilities, and facility modifications or additions.

  • Participates as a functional member for risk assessments including but not limited to:  facility cross-contamination assessments.

  • Work closely with cross-functional colleagues and teams to evaluate deviations/investigations as applicable

  • Work closely with the CSV (computer system validation) group to help drive computer system validation (CSV) for stand-alone systems as they pertain to manufacturing/packaging areas.


Education and Experience

  • Bachelor’s degree with 6+ years of related experience.


Alcami Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.

  • Follows all safety policies and leads by example a safety first culture.

  • Produces high quality work product with a focus on first time right.

  • Complies with the company code of conduct and policies and regulatory standards.


Alcami Core Leadership Competencies

  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.


Functional Competencies

  • Excellent knowledge of quality assurance reviews of validations documentation.

  • cGMP training and excellent understanding of requirements.

  • Excellent knowledge of pharmaceutical GMP environment.

  • Excellent understanding of and ability to utilize Pro Cal.

  • Excellent understanding of and ability to utilize Kaye Validator 2000.

  • Excellent understanding of and ability to utilize Val Probes.

  • Excellent verbal and written communication skills.

  • Excellent mechanical skills.

  • Strong understanding of Excel.

  • Strong understanding of Word.

  • Strong positive team player.

  • Ability to train and mentor others.


Travel Requirements

  • Up to 5% travel required.


What We Offer You:

  • Competitive salary with career advancement opportunities

  • Profit sharing bonus plan

  • Medical, dental and vision coverage from day one

  • 401(k) with company match

  • Company paid vacation, holiday and sick-leave

  • Voluntary benefits including short & long term disability, life, accident, critical illness insurances


Job Requirements

(see job description above)
(Job number: 3957310)
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