Commissioning & Verification SME
- All US
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
The United States is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting remote opportunity for a Commissioning & Verification SME to join a major project for a global pharmaceutical organisation, located in the East Coast, with great longevity of employment possibility.
Responsibilities:
- Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams (See Role Summary.) Commissioning and Verification (aka Qualification) will follow the ASTM E2500 standard.
- Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstream. This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
- Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.
- Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
- Lead and participate in development and execution of complete verification documentation in accordance with internal Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
- Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
- Provide or arrange for development of complete verification documentation in accordance with internal Quality Standards and cGMP requirements for assigned work stream.
- Collaborate with matrix organization to optimize Change Control implementation and management.
- Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
- Assist C&V Lead with the preparation of C&V status reports: include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.
The ideal candidate will have:
- Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
- Minimum 4 years technical experience.
- Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
- Communication Skills: Excellent oral and written communication skills, including presentations.
- Ability to write clearly, concisely, and persuasively in a professional environment.
- Demonstrated ability to interact effectively with all levels of the organization.
- Demonstrated understanding of risk-based approach to commissioning & qualification.
- Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled).
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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