Job Description

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 is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation activities. Specific responsibilities include reviewing SOP\xe2\x80\x99s, composing/revising SOP\xe2\x80\x99s and validation master plans; supporting facility, utility, manufacturing equipment, laboratory equipment; 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. 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
\xc2\xb7 Performs the qualification and validation of equipment and systems.
\xc2\xb7 Assists in equipment selection and specification.
\xc2\xb7 Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
\xc2\xb7 Exercises judgment within defined procedures and practices to determine appropriate action.
\xc2\xb7 Maintains all documentation pertaining to qualification and validation.
\xc2\xb7 Develops procedures and/or protocols.
\xc2\xb7 Serves as information resource for validation technicians, contractors and vendors.
\xc2\xb7 Executes procedures and/or protocols.
\xc2\xb7 Composes/revises SOP\xe2\x80\x99s and master validation plans.
\xc2\xb7 Supports facility, utility, instruments and equipment.
\xc2\xb7 Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Education and Experience
\xc2\xb7 Bachelor\xe2\x80\x99s Degree with 2-4 years of related experience. Alcami Non-Negotiables
\xc2\xb7 Consistently demonstrates honesty and integrity through personal example.
\xc2\xb7 Follows all safety policies and leads by example a safety first culture.
\xc2\xb7 Produces high quality work product with a focus on first time right.
\xc2\xb7 Complies with the company code of conduct and policies and regulatory standards. Alcami Core Leadership Competencies
\xc2\xb7 Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
\xc2\xb7 Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
\xc2\xb7 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.
\xc2\xb7 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.
\xc2\xb7 Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
\xc2\xb7 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
\xc2\xb7 Good knowledge of quality assurance reviews of validations documentation.
\xc2\xb7 cGMP training and basic understanding.
\xc2\xb7 Good knowledge of pharmaceutical GMP environment.
\xc2\xb7 Basic knowledge of Kaye Validator 2000.
\xc2\xb7 Good understanding of and ability to utilize Pro Cal.
\xc2\xb7 Strong communication skills (oral and written).
\xc2\xb7 Strong mechanical skills.
\xc2\xb7 Strong working knowledge of Microsoft Office applications.
\xc2\xb7 Positive team player. Supervisory Responsibilities
\xc2\xb7 None Decision Making and Supervision Required
\xc2\xb7 Applies job skills, company policies and SOPs to complete a variety of tasks.
\xc2\xb7 Receives general instructions on routine work, detailed instructions on new projects or assignments. Travel Requirements
\xc2\xb7 Up to 5% travel required. 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. 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.




What We Offer You:

• Competitive salary with career advancement opportunities
• 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

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, sexual orientation, 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.