CSV Project Manager

CSV Project Manager - 6 Month Contract - USA

Are you a CSV Project Management professional with experience in ERP Integration? Are you looking to take the next step in your career and be part of an exciting chemical API manufacturing plant? Then the position of CSV Project Manager is exactly what you’re looking for.

This is your chance to work for a company that is an industry-leading CMO who are focusing on the development of medicines to treat multiple cancers. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member. They are led by an experienced executive team that are leading them to a bright and exciting future.


Main Responsibilities:

• Lead the implementation in how computerized systems become validated to ensure the approach and execution aligns to industry. Scope includes IT, Execution Systems, and ERP (Epicor).
• Provide guidance, and where required, lead the development of life cycle documentation. Provide guidance in SOP development.
• Act as a high-level technical resource for interpretation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.
• Support internal and external audits as the point of contact for computerized systems validation. Lead and ensure local periodic review as well as required schedule tasks conform to the developed schedule.
• Support the implementation and adoption of the global CSV program and remediation. Support data integrity implementation and remediation for systems within CSV program. Drive and participate in continuous improvement efforts related to CSV program.
• Works to ensure the organization receives the emphasis and resources required to achieve all CSV site and corporate goals.

EXPERIENCE REQUIRED:

• A minimum of ten (10) years related experience and/or training; or an equivalent combination of education and experience.
• Ability to complete tasks with limited oversight
• Ability to translate regulatory guidance (GMP), laws, into executable and defendable lifecycle documentation
• Depth of understanding of regulations governing computer systems and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, data integrity guidance
• Understanding of modern and risk based validation executions
• Understanding/experience of ERP implementation projects (Epicor ideal)
• Background in Lifesciences and/or Pharma/Biotech industries (or understanding of bioprocessing and support processes)
• Direct experience with IT and MFG automation systems (Delta V) supporting GMP manufacturing

If this of interest to you please apply!

The candidate must have the rights to work in the location stated in the job advert.

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