Experience: 1 + Years
Education: Tech/Vocational Cert/Apprenticeship
Location: New York, NY, 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 with experience in the Biotech Industry. The right candidate will have background / experience in blood processing and/or biologics. The Senior CQV Specialist will work in the field on CQV projects. This position may involve project management and team leadership. The right candidate will have experience writing and execution validation / qualification protocols for utilities, process systems, and support systems. Preferable experience will include leading biotech related projects, managing a team, keeping track of scope and day to day interface with clients. This assignment based position is currently located in Long Island, NY.
- Providing client support for leading commissioning, qualification and validation projects either independently or as part of a larger team
- May include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and qualification protocols, cleaning validation, computer validation, sterilization validation, data reviews, SOP development, development of final reports, and leading others in similar activities
- Extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements therefore excellent communication skills (written and verbal) are required
- Proficiency in the use of Microsoft Word, Project, and Excel is required. Individual must be self-motivating, detail oriented, with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team. Must be capable of working independently as well as in leadership positions
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
- BS or MS in engineering, computer sciences, life sciences, or equivalent work experience
- 8+ years validation experience in the biotechnology and/or pharmaceutical industries required
- Knowledge of Blood Processing and/or Biologics
- A thorough and working knowledge of GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems and validation of processes
- Candidates must have excellent written and verbal communication skills, experience with Microsoft Word, Excel, Project, with hands-on experience working in a corporate setting, and as a productive and supportive member of a project team
- Preferred candidates will have demonstrated validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000 and/or Kaye Digistrip
- A thorough knowledge of good manufacturing practices and good documentation practices
- Must have the ability to work independently on projects and/or manage their assigned projects, while being provided oversight from a more senior team member
- 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.