What are the responsibilities and job description for the Validation Engineer position at Apex Systems?
Job Details
Job#: 2065489
Job Description:
Apex Systems has partnered with a leading contract development and manufacturing organization to fill a Validation Engineer position in their Grafton, WI site.
Ideal candidates will come from a Quality Engineering background and/or possess a chemical engineering degree. Candidates MUST be familiar with GMPs. The main task will be writing and validating IQOQ's.
If interested, please apply with an updated resume.
Job Title: Validation Engineer
Location: Grafton, WI
Onsite: 5 days per week
Duration: contract
Hourly Rate: Negotiable
Summary: The Validation Engineer is responsible for managing all technical aspects of assigned products and/or new processes in manufacturing. This includes writing and validating IQOQs, preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.
Essential Duties, Responsibilities, and Accountabilities:
Education and Experience:
Other Requirements:
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Job Description:
Apex Systems has partnered with a leading contract development and manufacturing organization to fill a Validation Engineer position in their Grafton, WI site.
Ideal candidates will come from a Quality Engineering background and/or possess a chemical engineering degree. Candidates MUST be familiar with GMPs. The main task will be writing and validating IQOQ's.
If interested, please apply with an updated resume.
Job Title: Validation Engineer
Location: Grafton, WI
Onsite: 5 days per week
Duration: contract
Hourly Rate: Negotiable
Summary: The Validation Engineer is responsible for managing all technical aspects of assigned products and/or new processes in manufacturing. This includes writing and validating IQOQs, preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.
Essential Duties, Responsibilities, and Accountabilities:
- Collaborate closely with Engineering and Chemical Development departments for equipment validation.
- Validate new equipment according to approved testing plans and report results accordingly.
- Develop and write GMO qualifications for new pharmaceutical equipment using templates.
- Adhere to personal moral, ethical, legal, and behavioral conduct in compliance with the Code of Conduct.
- Implement and adhere to all applicable SHE, DEA, and cGMP regulations.
- Familiarity with equipment specification and qualification, deviations, CRs, MBRs, IQOQs, writing procedures, Visalia, and Blue Mountain maintenance system is a plus.
Education and Experience:
- A 4-year degree in Chemical Engineering is desired, along with 0-5 years of hands-on experience in a pharmaceutical or fine chemical batch plant.
- Experience with Drug Substance/API Pharma processing equipment.
- Ability to review and summarize data from equipment validation studies and write summary reports for Quality approval.
Other Requirements:
- Excellent verbal and written communication skills.
- Highly conscientious and detail-oriented.
- Ability to work efficiently with people of all levels and cultures.
- Team player.
- Self-starter and initiator.
- Ability to manage projects and prioritize appropriately.
- Knowledge of organic chemistry.
- Knowledge of standard process equipment.
- Excellent computer skills (MS Office).
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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