Director Computer System Validation Csv Jobs in Rochester, NY

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 hardcopies 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 using MS Word and ExcelAn understanding of production activities and/or mechanical aptitude
• Knowledge of production equipment operations
• Knowledge of instrumentation, control systems, and production equipment
• Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity; seeking guidance where necessary to implement solutions to issues that are identified
• Ability and willingness to support transactional and administrative functions within the department.
• Requires good teamwork, excellent communication, interpersonal and organization skills.
SCOPE OF DECISION-MAKING: Decisions require some judgment and critical thinking ability. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
Compensation range
20,19 - 25,00 USD
*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
A Smarter Total Compensation Package
At Unither, your base salary is just the beginning. Our Total Rewards include:

• 100% employer-paid medical premiums (a $2,000-$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility
• And more-because we invest in your health, your future, and your peace of mind.

It's a package designed to reward impact-not just hours worked.
More Than Just a PaycheckAt Unither, we don't just offer competitive hourly wages-we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!
Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.