Senior Validations Engineer

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Job Description
CURRENTLY OFFERING ***$3,000 SIGN ON BONUS***
MARKET COMPETITIVE WAGES
COMPREHENSIVE BENEFITS PACKAGE STARTING DAY ONE
*paid out upon hire and in two additional installments. Internal candidates are not eligible for sign on bonus
Position Summary
The Senior Validation Engineer 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 and laboratory 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 of the Alcami core competencies and non-negotiables, as well as demonstrated experience in small volume parenteral operations in vials and pre-filled syringes.
Essential Functions
Performs the qualification and validation of equipment and systems.
Assists in equipment selection and 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.
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.
Education and Experience
Bachelor’s Degree (Chemistry, Pharmaceutical Sciences, and Engineering) required
5 years of qualification and validation (Equipment & Systems, Facilities, Utilities) experience in small volume parenteral operations (vials and pre-filled syringes) required
Hands on experience in commissioning and qualifying steam and dry heat sterilizers, liquid filling lines, isolators, freeze dryers, terminal sterilizers, parts washers and/or
Critical utilites, water for injections, clean compressed gases and/or
Controlled environments and operations (ISO)
CDMO, combined products, small molecules, and biologics experience a plus.
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
Passion for customers. Understands Alcami customers. Gets to the heart of the matter. Uses that insight to provide value.
Thinks strategically. Quickly identifies and acts on opportunities. Combines forethought with action. Understands the external and internal environment and the impact on Alcami.
Acts decisively. Makes and acts on decisions quickly. Fosters the same in others and the courage to enhance risk-taking for the business.
Drives performance. Holds self and others accountable. Creates an environment that enables others to perform at their best.
Works collaboratively. Actively creates and promotes cross-boundary collaboration to achieve better results.
Functional Competencies
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 understanding of and ability to utilize CAL MAN.
Excellent verbal and written communication skills.
Excellent mechanical skills.
Strong working knowledge of Microsoft Office applications.
Positive team player.
Ability to train and mentor others.
Travel Requirements
Up to 5% travel required.
Job Requirements
(see job description above)

Company info

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