What are the responsibilities and job description for the Qualification Engineer position at LanceSoft, Inc.?
Qualification Engineer
On-site
Qualification Engineer
1. Education: A bachelor's or master's degree in engineering, preferably in chemical or mechanical engineering, or a related field.
2. Experience: 5 years of relevant experience in the pharmaceutical industry, with a focus on CQV activities. This experience should include hands-on experience in executing validation protocols, but is focused more on the development of these documents for equipment qualification, and commissioning activities.
3. Expertise in regulatory requirements: Strong knowledge and understanding of FDA regulations, GMP (Good Manufacturing Practices), and other relevant regulatory guidelines applicable to the pharmaceutical industry.
4. Validation and qualification experience: Extensive experience in developing and executing validation protocols, including equipment, facilities and utilities qualification.
5. Project management skills: Ability to effectively manage and lead CQV projects, including developing project plans, coordinating with cross-functional teams, ensuring adherence to timelines, and delivering projects within budget.
6. Technical skills: Proficiency in utilizing various CQV tools, methodologies, and techniques, such as risk assessments, validation master plans, validation protocols, and data analysis. Familiarity with computerized systems validation (CSV) and automated systems is a plus.
7. Leadership and communication: Strong leadership skills, with the ability to effectively communicate and collaborate with cross-functional teams, stakeholders, and clients. Excellent oral and written communication skills are necessary for preparing reports, presenting validation findings, and training personnel.
8. Problem-solving and critical thinking: Strong analytical and problem-solving skills to identify and resolve deviations in a timely manner and ensure compliance with regulatory requirements.
9. Quality mindset: A strong commitment to quality and compliance, with an understanding of quality systems and continuous improvement concepts like Lean Six Sigma.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
• Four options of Medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
On-site
Qualification Engineer
1. Education: A bachelor's or master's degree in engineering, preferably in chemical or mechanical engineering, or a related field.
2. Experience: 5 years of relevant experience in the pharmaceutical industry, with a focus on CQV activities. This experience should include hands-on experience in executing validation protocols, but is focused more on the development of these documents for equipment qualification, and commissioning activities.
3. Expertise in regulatory requirements: Strong knowledge and understanding of FDA regulations, GMP (Good Manufacturing Practices), and other relevant regulatory guidelines applicable to the pharmaceutical industry.
4. Validation and qualification experience: Extensive experience in developing and executing validation protocols, including equipment, facilities and utilities qualification.
5. Project management skills: Ability to effectively manage and lead CQV projects, including developing project plans, coordinating with cross-functional teams, ensuring adherence to timelines, and delivering projects within budget.
6. Technical skills: Proficiency in utilizing various CQV tools, methodologies, and techniques, such as risk assessments, validation master plans, validation protocols, and data analysis. Familiarity with computerized systems validation (CSV) and automated systems is a plus.
7. Leadership and communication: Strong leadership skills, with the ability to effectively communicate and collaborate with cross-functional teams, stakeholders, and clients. Excellent oral and written communication skills are necessary for preparing reports, presenting validation findings, and training personnel.
8. Problem-solving and critical thinking: Strong analytical and problem-solving skills to identify and resolve deviations in a timely manner and ensure compliance with regulatory requirements.
9. Quality mindset: A strong commitment to quality and compliance, with an understanding of quality systems and continuous improvement concepts like Lean Six Sigma.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
• Four options of Medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
Salary : $54 - $72
