Overview
Validation Technician Jobs in New York, New York, USA at Unither Pharma
Location: New York
Validation Technician
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives for as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single-dose products, 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 300 employees.
Your role
Reporting to the Quality Director,
Job Summary: Assists validation efforts by executing/supporting equipment, cleaning, and process qualifications, taking and delivering samples, collecting and compiling data for validation reports, maintaining the Validation Document Library, and ensuring test equipment and documentation systems are up-to-date.
Essential Functions/Responsibilities:
Assist in executing validation protocols (commissioning/qualification, PQ, and Controls) for facilities, manufacturing equipment, processes, cleaning, and utilities.
Perform sampling of in-process/intermediate products and surface swabbing as per protocols.
Maintain protocols and system documentation for regulatory review.
Ensure validation activities are documented and maintained according to procedures.
Use basic support equipment (computers, sensors, multi-meters) to support protocols.
Gather and organize relevant documentation such as batch records, certificates of analysis, logs, and qualifications.
Coordinate with departments including Operations, Engineering, QA, QC, and Tech Services to ensure validation activities are completed.
Your profile
Education & Experience:
HS Diploma/GED with minimum 2 years in an FDA regulated environment, GMP setting preferred.
AAS with 1 year experience in an FDA regulated environment, GMP setting preferred.
BS with 0 experience.
Skills include strong written communication, basic mechanical knowledge, ability to learn equipment operation, use of hand tools, knowledge of computer applications, and understanding of manufacturing processes. Leadership capabilities and understanding of material handling are a plus.
Must be able to communicate in English, both written and verbal.
Knowledge, Skills & Abilities:
Basic math skills, understanding of production activities, mechanical aptitude, and knowledge of equipment and instrumentation.
Ability to recognize quality-impacting situations and seek guidance.
Supportive team player with good communication and organizational skills.
Scope of Decision-Making: Performs routine duties with some judgment, following detailed instructions.
Supervision Level: Individual contributor.
Internal/External Contacts: Mainly within the department; occasionally outside for information exchange.
Physical & Environmental Requirements:
Office environment with visits to manufacturing areas.
Extended computer work, safety gear as required, ability to gown and enter controlled areas, and transport samples.
Ability to meet project deadlines.
Compensation Range: $20.00 – $24.00 USD
* Range reflects minimum and maximum; actual salary depends on various factors.
Benefits include:
401K with up to 6% match.
Annual 4% retirement contribution.
Quarterly or annual performance bonuses.
11 paid holidays.
Health, dental, vision insurance with premiums paid by Unither.
Health Savings Account contributions.
Life insurance coverage.
Learn more about us:
We are a dynamic company driven by growth, with a culture based on respect, responsibility, trust, courage, and innovation. We empower our employees with autonomy and support their development in a positive work environment.
Join us and make a difference!
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Title: Validation Technician
Company: Unither Pharma
Location: New York, New York, USA
Category: Manufacturing / Production (Quality Engineering), Quality Assurance – QA/QC (Quality Engineering, Quality Control / Manager, Quality Technician/ Inspector)
