Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support - Net2Source
Warren, NJ 07059
About the Job
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Job Description: This role is 100% Onsite
Work Schedule: Mon - Fri, Business Hours
1. PURPOSE AND SCOPE OF POSITION:
The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
2. REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
" Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
" Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
" Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
" Familiarity with 21 CFR Part 11 compliance.
" Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
" Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
" Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems
" Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas
" Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
" Ability to interact effectively with cross-functional groups.
" Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
" Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals and drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
" Strong computer skills in Microsoft Office Suite Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
3. DUTIES AND RESPONSIBILITIES
" Manage projects of limited scope and complexity.
" Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
" Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
" Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
" Create all documents in compliance with Client standards and policies.
" Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
4) EDUCATION AND EXPERIENCE
a. BA/BS degree required, BS or more advanced degree in science/engineering preferred
b. Minimum 4 years of equipment qualification execution and technical writing experience in FDA regulated industry (pharmaceutical/medical device/biotechnology)
Additional Job Requirements:
Lab w/ blood & animal
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
Job Description: This role is 100% Onsite
Work Schedule: Mon - Fri, Business Hours
1. PURPOSE AND SCOPE OF POSITION:
The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
2. REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
" Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
" Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
" Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
" Familiarity with 21 CFR Part 11 compliance.
" Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
" Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
" Preferred experience executing temperature/humidity mapping qualifications for controlled storage areas, controlled temperature units (incubators, refrigerators, freezers), and cryogenic storage systems
" Preferred experience executing airflow visualization qualifications (smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas
" Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
" Ability to interact effectively with cross-functional groups.
" Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
" Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals and drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
" Strong computer skills in Microsoft Office Suite Word, Excel, Power Point, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
3. DUTIES AND RESPONSIBILITIES
" Manage projects of limited scope and complexity.
" Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
" Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls.
" Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
" Create all documents in compliance with Client standards and policies.
" Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
4) EDUCATION AND EXPERIENCE
a. BA/BS degree required, BS or more advanced degree in science/engineering preferred
b. Minimum 4 years of equipment qualification execution and technical writing experience in FDA regulated industry (pharmaceutical/medical device/biotechnology)
Additional Job Requirements:
Lab w/ blood & animal
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
Source : Net2Source
