Validation Project Manager
Boston, MA
IPS is seeking a talented and motivated Validation Project Manager to join our growing team in the Greater Boston Area. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Additional duties and responsibilities include:
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Directly responsible for the successful delivery of commissioning and compliance projects to IPS’ clients. Lead multiple concurrent small, mid-sized, or large projects on behalf of IPS.
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IPS point of contact to client for overall project delivery. Runs meetings, communicates status and project issues, and facilitates general project coordination activities.
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Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS clients or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
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Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
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C/Q/V Master Plans
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Commissioning Forms
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C/Q/V Protocols and Summary Reports
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Standard Operating Procedures
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Impact Assessments
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Specifications (URS/FRS/DDS)
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FATS/SATs
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Perform and manage others during field/site activities including, but not limited to, the following:
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Attend and witness FATs and SATs as a representative of IPS clients.
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Execution of commissioning forms and witnessing of vendor start-up and testing.
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Execution of C/Q/V protocols.
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Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
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Perform and manage staff in compiling data packages and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
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Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.
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Audit project deliverables to assure compliance with established standards. Review work of assigned project team. Assure quality of IPS project work.
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Act as an IPS representative for developing new opportunities and continue to support repeat business.
Qualifications & Requirements:
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Bachelors degree in Engineering required
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5-10+ years applicable experience required
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Experience with Biotech equipment and facilities, CIP/SIP, cleaning validation, and process validation is desired
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Experience in the pharmaceutical / biotech industry is strongly preferred
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Must be self-sufficient and effectively work with limited to no supervision
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Must be able to work and lead the team in the delivery of projects
To apply for this position, please send your resume to careers@ipsdb.com for immediate consideration.