Job Description
Join to apply for the Computer Systems Validation Specialist role at Unither Pharmaceuticals
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Join to apply for the Computer Systems Validation Specialist role at Unither Pharmaceuticals
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
Your role
Reporting to the Quality Director ,
JOB SUMMARY:
This is a team-oriented position with the individual actively coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer systems as well as verifying the systems are being maintained in a validated state. Generates applicable validation project plans and risk assessments. Responsibilities will also include other qualification and validation activities such as but not limited to equipment qualifications, utility recertifications, cleaning recertifications, and recertification of sterile processes.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Computer Systems Validation Activities (50%)
Review and develop User Requirement Specifications, Functional and Design Specifications. If completed externally, obtain these documents prior to validation planning.
Generate validation project plans with responsibilities and actions.
Collaborate with departments to develop risk assessments, controls, and mitigation strategies.
Develop, write, and execute qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance, including system and user acceptance testing, and generate summary reports.
Organize all qualification documentation throughout the validation process.
Create SOPs specific to computer system validation, including updates for hardware, firmware, and software changes.
Qualification Protocols and Documentation (30%)
Develop and execute qualification protocols for manufacturing, processing, and packaging equipment and facilities.
Ensure validation activities are included in project plans, with proper documentation and investigation of deviations.
Draw conclusions based on data, observations, and deviations.
Coordinate with other departments to ensure validation activities are completed.
Validation Protocols and Reports (20%)
Write validation protocols for process validations.
Write final reports following validation criteria.
Perform sampling and testing as per protocols, review results, and maintain documentation.
Stay updated with industry practices and modify protocols accordingly.
Your profile
EDUCATION & EXPERIENCE:
Bachelor’s degree in a science or engineering discipline preferred, or associate degree with relevant experience.
Minimum 3 years of relevant experience for associate degree candidates; co-op/internship experience preferred.
Experience in IT or OT departments is required.
0-2 years of relevant work experience if holding a degree in lieu of experience.
KNOWLEDGE SKILLS & ABILITIES:
Stay current with cGMP validation trends and industry standards.
Effective communication skills for technical requirements.
Ability to manage multiple projects and adapt to scope and timeline changes.
Understanding of FDA validation requirements.
Data analysis skills and knowledge of computer system validation to meet FDA and Annex 11 standards.
SCOPE OF DECISION-MAKING: Routine analytical judgment within guidelines, involving fact analysis to determine actions.
LEVEL OF SUPERVISION: Project direction of peers, including assigning and reviewing work.
CONTACTS: Regular internal and external contacts, including with subordinates, departments, and occasionally outside organizations.
PHYSICAL REQUIREMENTS/ENVIRONMENT:
Office environment with visits to manufacturing areas.
Extended computer work, safety gear, and gowning required.
Sitting 75%, standing/walking 25%, with ability to transport samples.
Work under project deadlines.
Compensation Range
USD 65,000.00 - 75,000.00, determined by experience and qualifications.
Learn more about us
We foster a culture based on Respect, Responsibility, Trust, Courage, and Innovation, empowering employees with autonomy and growth opportunities.
Join us and make a difference!
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Job Tags
Work experience placement, Internship, Work at office,