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Sr. Validations Engineer - GMP Manufacturing

NCBiotechMorrisville, NC, US

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Sr. Validations Engineer - GMP Manufacturing

Location : US-NC-Morrisville

ID : 2025-1683

Category : Validation

Position Type : Full-Time

Working Hours : 1st Shift : Monday - Friday, 8 : 00am - 5 : 00pm

Job Summary

The Senior Validation Engineer is accountable for driving results in a fast-paced environment by supporting pharmaceutical validation activities. The Senior Validation Engineer will support the implementation and execution of Alcami's validation program for our drug product manufacturing facilities that comply with company policies and procedures. This includes commissioning and qualification of new equipment, instrumentation, utilities, facilities, cleaning validation, and computerized systems; validation lifecycle activities to include periodic review; requalification and maintenance of site validation plans. The role will support site change control activities to include validation impact assessment, updates to procedures and validation documentation deliverables, and commissioning and qualification activities, support regulatory and client audits, audit preparation activities, and observation responses and remediation activities. In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required.

On-Site Expectations

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

Responsibilities

Performs the commissioning, qualification, and validation of utilities, equipment, and systems.

Performs the periodic review and requalification of utilities, equipment, and systems.

Manages the validation documentation lifecycle from draft through archive to include procedure, requirements, specifications, and protocols. Maintains the qualified equipment, instrument, utilities, and systems in compliance with policies, guidelines, and procedures.

Collaborates with project teams in instrumentation, equipment, and computerized system requirement and specification development.

Supports client and regulatory audits and inspection preparation activities to include documentation and protocol identification, review, and preparation.

Supports client and regulatory audit and inspection with prompt detailed responses and documented evidence as required.

Supports client and regulatory responses and remediation activities; collaborates with site SME in development and review of responses; executes remediation activities associated where validation support is required.

Collaborates with cross functional team to maintain commissioning, qualification, and validation programs.

Exercises judgment within defined procedures and practices to determine appropriate action.

Serves as information resource for validation technicians, contractors, and vendors.

Drafts department SOPs and Training Modules.

Ensures maintenance of equipment database.

Acts as a certified trainer.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Performs deviation investigations and helps to implement CAPA and re-validation as necessary.

Other duties as assigned.

Qualifications

Bachelor's degree in science or engineering field (Chemistry, Pharmaceutical Sciences, and Engineering) required.

8+ years of qualification and validation (Equipment & Systems, Facilities, Utilities).

Experience with drug product manufacturing (vials and pre-filled syringes).

A minimum of eight years of experience in production, engineering, environmental monitoring, quality control, mechanical or related fields are preferred.

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 utilities, water for injections, clean compressed gases, controlled environments and operations.

CDMO, combined products, small molecules, and biologics experience a plus.

Knowledge, Skills, and Abilities

Strong knowledge of cGMPs, regulations, policies, and procedures applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.

Good written and oral communication skills.

Good math skills.

Excellent knowledge of pharmaceutical cGMP environment.

Excellent understanding of and ability to utilize maintenance management systems.

Excellent understanding of and ability to utilize document management systems.

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.

Strong working knowledge of Microsoft Office applications.

Positive team player.

Ability to be trained and to mentor.

Ability to act independently.

Ability to interact well with clients and regulatory agents.

Ability to interact well with employees at all levels.

Ability to act as technical consultant.

Uses professional concepts and company policies and SOPs to solve a variety of problems.

Receives minimal instruction on day-to-day work, general instructions on new assignments.

Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis, and understand Six Sigma concept.

Travel Expectations

Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation 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, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. 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.

About Us

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, 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, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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