Experience: 3 + Years
Education: Tech/Vocational Cert/Apprenticeship
Location: Morris Plains, NJ, US
In order to apply for this position, applicants MUST meet the following criteria. If your resume does not match these criteria, you will not be able to apply for this position.
Overview / Responsibilities
Amec Foster Wheeler is currently recruiting for a project assigned CQV Specialist II with experience in the Biotech Industry. The CQV Specialist II will work in the field on CQV projects. This may involve working under a CQV project manager or senior specialist.
- Providing client support for commissioning, qualification and validation services. This may include generation of documents such as design qualification, equipment, facility and utility commissioning and qualification, cleaning validation, computer validation, sterilization validation, data reviews, SOP development and development of final reports
- The ability to coordinate cross-functional activities with QA, Engineering, Operations and QC during the execution of protocols
- The ability to assure that all activities are performed in compliance with approved validation/qualification protocols and SOPs to support company and validation policies as well as current regulatory requirements/guidelines is required
Note: Candidate is expected to travel to a client and/or field site - per diem may be included in the assignment package
Skills / Qualifications
Skills / Qualifications
- Engineering degree – Chemical Engineering preferred or Life Sciences. Suitable industry experience in lieu of educational requirements may be acceptable
- Must be familiar with cGMPs and pharmaceutical and biopharmaceutical unit operations
- Must have a basic understanding of commissioning and qualification and willingness to learn skills required to author and execute DQ/FAT/SAT/CTPIQ/OQ/PQ/PV documents, developing SOPs, final reports and author/adhere to the validation and quality policies/procedures/guidelines
- Must be familiar with cGMPs and current industry guidelines, standards, P&IDs, work in a construction environment, must be computer literate
- Validation experience in a pharmaceutical/biotech industry with a minimum of 3 years of experience
- The ability to travel is required
- Must be legally authorized to work in the USA for any employer other than current employer
We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.