What are the responsibilities and job description for the Validation Technician position 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
Assists validation efforts in many ways including the following: executes/supports equipment, cleaning, and process qualifications, takes and delivers samples, collects and compiles data for validation reports, assists in maintaining of the Validation Document Library, maintains test equipment and documentation system.
Essential Functions / Responsibilities
Assists in the execution of validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
Performs proper and timely sampling of in-process/intermediate products and surface swabbing for testing as outlined by validation/qualification protocols.
Maintains protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
Ensures protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are maintained according to procedure.
Understanding use of basic support equipment (i.e. computers, temperature/humidity sensors, multi-meters, etc.) to support protocol executions.
Gathers photocopies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw materials certificates of analysis.
Interacts with and coordinates compliance efforts with other departments including, but not limited to: Operations, Engineering, QA, QC laboratories and Tech Services to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
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.
Skills
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.
An 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. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
LEVEL OF SUPERVISION PROVIDED: Individual contributor, not responsible for the work others.
INTERNAL / EXTERNAL CONTACTS: Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters, or contacts with other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.
Physical Requirements/Environment
Traditional office environment, with frequent visits to other areas of the facility.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Sitting 75% of the day; standing or walking 25%.
Ability to gown and enter controlled manufacturing areas.
Ability to collect and transport validation samples.
Frequently subjected to project deadlines.
Compensation Range
20.00 - 24.00 USD
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!
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
Assists validation efforts in many ways including the following: executes/supports equipment, cleaning, and process qualifications, takes and delivers samples, collects and compiles data for validation reports, assists in maintaining of the Validation Document Library, maintains test equipment and documentation system.
Essential Functions / Responsibilities
Assists in the execution of validation protocols (commissioning/ qualification, PQ, and Controls) for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
Performs proper and timely sampling of in-process/intermediate products and surface swabbing for testing as outlined by validation/qualification protocols.
Maintains protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
Ensures protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are maintained according to procedure.
Understanding use of basic support equipment (i.e. computers, temperature/humidity sensors, multi-meters, etc.) to support protocol executions.
Gathers photocopies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw materials certificates of analysis.
Interacts with and coordinates compliance efforts with other departments including, but not limited to: Operations, Engineering, QA, QC laboratories and Tech Services to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
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.
Skills
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.
An 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. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
LEVEL OF SUPERVISION PROVIDED: Individual contributor, not responsible for the work others.
INTERNAL / EXTERNAL CONTACTS: Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters, or contacts with other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.
Physical Requirements/Environment
Traditional office environment, with frequent visits to other areas of the facility.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Sitting 75% of the day; standing or walking 25%.
Ability to gown and enter controlled manufacturing areas.
Ability to collect and transport validation samples.
Frequently subjected to project deadlines.
Compensation Range
20.00 - 24.00 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.
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!
