Job Brief

The Validations Specialist supports general pharmaceutical validation activities.

Think Different. Do Different. Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

About Alcami

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Validations Specialist I 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 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

• 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 an 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.

Education and Experience

• Bachelor's Degree with 2-4 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

• Good knowledge of quality assurance reviews of validations documentation.


• cGMP training and basic understanding.


• Good knowledge of pharmaceutical GMP environment.


• Basic knowledge of Kaye Validator 2000.


• 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.


• Positive team player.

Travel Requirements

• Up to 5% travel required.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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