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.

Are you interested in joining our team?

The Validations Specialist 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, manufacturing equipment, cleaning and process validation projects; conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; monitoring compliance; developing documentations as required for projects; and consulting on validation and cGMP questions and issues.

100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

• Performs the qualification and validation of equipment and systems.
• Assists in equipment selection and specification.
• Works on problems of moderate 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 and/or protocols.
• Serves as information resource for validation technicians, contractors, and vendors.
• Executes procedures and/or protocols.
• Composes/revises SOP's and master validation plans.
• Supports facility, utility, instruments, and equipment.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as asigned.

• Bachelor's Degree in Engineering, Chemistry, Biology, or related field.
• 2-4 years of related experience.

• Good knowledge of quality assurance reviews of validations documentation.
• cGMP training and basic understanding.
• Good 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.

• Up to 5% travel is required.

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.