What are the responsibilities and job description for the Equipment Validation Associate position at Pii, A Jabil Company?
Job Overview
Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validation of facilities, instruments, and equipment, performing, and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for aseptic and non-aseptic production environment.
Focus of position: Calibration/Metrology/Equipment Qualification
Manages, coordinates, performs, and reports all activities related to the calibration of equipment used at Pharmaceutics International Incorporated. Support other validation activities such as equipment commissioning, qualifications, and process validations.
Responsibilities
The essential functions of the position include, but are not limited to:
Performs calibrations for all equipment and instrumentation involved in, but not limited to, manufacturing processes at Pharmaceutics International Incorporated.
Understands equipment/instrument specifications, calibrations, out of specifications, tolerance limits for different instruments
Creates documentation that accurately describes the procedures required to effectively calibrate equipment.
Provides initial Standard Operating Procedure (SOP) training to all responsible personnel.
Assists in the troubleshooting of equipment and contacts maintenance for all repairs when necessary.
Review equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations prepared by other team members.
Assures that assigned obligations are conducted in accordance with cGMPs, or any other company approved documentation.
Interacts with peers and vendors to ensure project timelines are achieved and offering satisfactory alternatives when necessary.
Execute protocols and related activities associated with cleaning and process validation, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.
Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions.
Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to products and processes.
Coordinate with cross functional teams for internal and external audits. Provide all required documentation. Interacts with other departments to ensure project activities are performed in a timely manner.
Scans, archives, and organizes all validation documentation.
Continues to increase knowledge of latest process technologies within the pharmaceutical industry.
Additional Functions And Responsibilities As Needed Or Assigned.
Essential Specialized Knowledge and/or Skills to Perform Job:
Ability to read, write and speak English fluently.
Ability to communicate effectively to team members on a routine basis
Knowledge of cGMPs, manufacturing procedures of Pii’s product line and company policies/regulations; knowledge of manufacturing operations and validation guidelines – SOPs, FDA, OSHA, DEA and MSDS requirements.
Qualifications
Education/Experience: Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Associate with a minimum of 2 years experience within the pharmaceutical, cosmetic, or food industry, specifically with Metrology/Calibrations.
Competency
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical – Working knowledge of cGMPs and internal SOPs; identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.
Customer Service – Responds to requests for service and assistance with professionalism, courtesy and confidence.
Technical Skills – Ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action.
Interpersonal Skills – Interacts with management and non-management employees across all department within Pii and outside clients.
Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications.
Team Work – Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas.
Diversity – Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings.
Ethics – Works with integrity and ethically; maintains confidentiality
Professionalism – Treats others with respect and consideration.
Attendance/Punctuality – Is consistently at work and on time.
Dependability – Follows instructions, responds to management direction; takes responsibility for own actions.
Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
Safety and Security – Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements.
Language Ability – Ability to read, write and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Math Ability – Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents.
Reasoning Ability – Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
Computer Skills – Basic computer skills, i.e., Outlook, Microsoft Word, Excel and PowerPoint
Physical Demands
The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing.
While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.
Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validation of facilities, instruments, and equipment, performing, and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for aseptic and non-aseptic production environment.
Focus of position: Calibration/Metrology/Equipment Qualification
Manages, coordinates, performs, and reports all activities related to the calibration of equipment used at Pharmaceutics International Incorporated. Support other validation activities such as equipment commissioning, qualifications, and process validations.
Responsibilities
The essential functions of the position include, but are not limited to:
Performs calibrations for all equipment and instrumentation involved in, but not limited to, manufacturing processes at Pharmaceutics International Incorporated.
Understands equipment/instrument specifications, calibrations, out of specifications, tolerance limits for different instruments
Creates documentation that accurately describes the procedures required to effectively calibrate equipment.
Provides initial Standard Operating Procedure (SOP) training to all responsible personnel.
Assists in the troubleshooting of equipment and contacts maintenance for all repairs when necessary.
Review equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations prepared by other team members.
Assures that assigned obligations are conducted in accordance with cGMPs, or any other company approved documentation.
Interacts with peers and vendors to ensure project timelines are achieved and offering satisfactory alternatives when necessary.
Execute protocols and related activities associated with cleaning and process validation, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.
Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions.
Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to products and processes.
Coordinate with cross functional teams for internal and external audits. Provide all required documentation. Interacts with other departments to ensure project activities are performed in a timely manner.
Scans, archives, and organizes all validation documentation.
Continues to increase knowledge of latest process technologies within the pharmaceutical industry.
Additional Functions And Responsibilities As Needed Or Assigned.
Essential Specialized Knowledge and/or Skills to Perform Job:
Ability to read, write and speak English fluently.
Ability to communicate effectively to team members on a routine basis
Knowledge of cGMPs, manufacturing procedures of Pii’s product line and company policies/regulations; knowledge of manufacturing operations and validation guidelines – SOPs, FDA, OSHA, DEA and MSDS requirements.
Qualifications
Education/Experience: Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Associate with a minimum of 2 years experience within the pharmaceutical, cosmetic, or food industry, specifically with Metrology/Calibrations.
Competency
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical – Working knowledge of cGMPs and internal SOPs; identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.
Customer Service – Responds to requests for service and assistance with professionalism, courtesy and confidence.
Technical Skills – Ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action.
Interpersonal Skills – Interacts with management and non-management employees across all department within Pii and outside clients.
Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications.
Team Work – Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas.
Diversity – Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings.
Ethics – Works with integrity and ethically; maintains confidentiality
Professionalism – Treats others with respect and consideration.
Attendance/Punctuality – Is consistently at work and on time.
Dependability – Follows instructions, responds to management direction; takes responsibility for own actions.
Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
Safety and Security – Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements.
Language Ability – Ability to read, write and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Math Ability – Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents.
Reasoning Ability – Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
Computer Skills – Basic computer skills, i.e., Outlook, Microsoft Word, Excel and PowerPoint
Physical Demands
- Specific vision abilities required include peripheral vision, depth perception, and ability to adjust focus.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing.
While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.
Salary : $65,000 - $75,000
