Senior Validations Specialist

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. 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 - 4:30pm.

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.

Qualifications

• Bachelor’s Degree in Engineering, Chemistry, Biology, or related field required.
• 5+ years of related experience required.

Knowledge, Skills, and Abilities

• 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.

Travel Expectations

• Less than 10% travel expected.

Physical Demands and Work Environment

The physical demands 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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.