Address
Form of work 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 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
• 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.
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.
Supervisory Responsibilities
• None
Decision Making and Supervision Required
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.
Travel Requirements
• 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.
#LI-Onsite
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 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
• 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.
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.
Supervisory Responsibilities
• None
Decision Making and Supervision Required
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.
Travel Requirements
• 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.
#LI-Onsite
