Validation Technician

Validation Technician

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 300 employees.

Your role

Reporting to the Director of Quality,

JOB SUMMARY:

Assists validation efforts in many ways including the following: executes/supports equipment qualifications, cleaning validations and recertifications, chamber (i.e., freezers, refrigerators, incubators) recertifications, and process validations, takes and delivers samples, collects and compiles data for validation reports, assists in maintaining the Validation Document Library, maintains test equipment and department documentation.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

* Assists in the execution of validation protocols ( qualification, process validations, and recertifications) for facilities, chambers, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.

* Performs proper and timely post cleaning sampling from manufacturing equipment. Confirms there is an appropriate amount of required sampling materials and supplies available. Orders are to be placed as needed to ensure supplies are maintained. Responsible for organization of supplies and materials, FIFO is consistently followed..

* Maintains department documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner. Participates in audits (i.e., customer and regulatory) and retrieves Validation documentation as requested.

* Ensures good documentation practices are followed during protocol executions, verifications, validation plans and summary reports generated during validation/ qualification activities are maintained according to procedure.

* Become proficient using temperature/humidity loggers along with the associated DT Pro software. Responsibilities will include, programing, reading, generating reports, as well as conducting routine maintenance per department procedure.

* Reviews documentation executed during validation activities and ensures completeness is performed contemporaneously. All applicable documentation is scanned and transferred to the activity's applicable project folder and all completed hard copies are filed accurately within the site's documentation room.

* Ensures all department testing equipment is maintained in a current calibrated state. Communicates and works with outside vendors to schedule, ship, track, and receive testing equipment to be sent for calibration. Confirms a current calibration certificate is received with each piece of testing equipment. Inventory and calibration status is maintained within Blue Mountain Regulatory Asset Manager (BMRAM)..

Your profile

EDUCATION & EXPERIENCE:

* HS Diploma/GED with minimum 2 years of experience in a FDA regulated environment, GMP production setting preferred.

* AAS with 1 year experience in a FDA regulated environment, GMP production setting preferred.

* BS with 0 experience.

* Above average written communication skills & writing abilities.

* Basic mechanical knowledge and aptitude.

* Ability to learn the operation and function of multiple pieces of equipment.

* Use of basic hand tools such as wrenches, screwdrivers, measuring devices.

* Knowledge of computer applications and current software is desirable.

* Knowledge of manufacturing processes and demonstrated leadership capabilities are preferred.

* General understanding of material handling machinery is advantageous.

KNOWLEDGE SKILLS & ABILITIES:

* Demonstrated basic math skills in multiplication, division, percentage calculation, significant figures, conversion from metric to standard measures (or inverse), and weight to volume measures (or inverse). This would include basic algebra and geometry.

* Familiarity…