Manager, Validation

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 Manager, Validations 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 documentation as required for projects; 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. The position requires superior leadership behaviors as well as expertise in functional competencies.

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

• Optimizes the qualification and validation of equipment, instrumentation and systems.
• Assists in equipment selection, specification, and negotiation of competitive pricing.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Maintains all documentation pertaining to qualification and validation.
• Develops procedures and/or protocols.
• Leads investigations as needed.
• Serves as information resource for validation technicians, contractors and vendors.
• Executes procedures and/or protocols.
• Drafts department SOP's and training modules.
• Reviews, composes/revises SOP's and master validation plans.
• Supports facility, utility and manufacturing equipment.
• Ensures maintenance of equipment database.
• Acts as a certified trainer.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Represents the department in meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
• Manages the day-to-day operations for assigned area.
• Ensures all staff members are fully trained.
• Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
• Effectively resolves quality issues and concerns in a timely manner.
• Creates strong and effective relationships with clients.
• Other duties as assigned.

• Requires a related Bachelor's degree with 6+years of relevant experience.
• Must have at least 2+ years of experience in management roles.

• 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.
• Good business acumen.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong attention to detail, as well as time and resource management.
• Good presentation skills.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Promote a safe environment for work.
• Comply with the general policy of the company.
• High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
• Communicate well orally both for internal customers and team members as well as external customers.
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners and colleagues at all levels.
• Highly goal and result oriented.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
• Can work independently with a high degree of self-motivation.
• Knows how to obtain support from different collaborations.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Very effective listening skills with the ability to hear attentively and process information correctly.

• Up to 10% travel expected.

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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, 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, and peripheral vision.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.