We represent ERP Quality and Validation professionals with active opportunities at pharmaceutical, biotech, medical device, and CDMO organizations. If your background is in validated systems and FDA-regulated manufacturing compliance, reach out.
We represent professionals whose careers are built around validated systems and GxP compliance in FDA-regulated manufacturing. If your work sits at the intersection of enterprise systems and regulated manufacturing operations, as an ERP validation lead, CSV specialist, quality systems manager, or related role, we want to understand where you want to take your career.
Our searches are specific. When we reach out, or when you contact us, it is because your background matches a real, scoped opportunity at a pharmaceutical, biotech, medical device, or CDMO organization.
We work with a focused number of candidates in this practice area, which means we invest the time to understand your background before reaching out about an opportunity.
We discuss your validated systems background, GxP experience, target life sciences sectors, and work preferences before anything else, including whether you are open to contract, permanent, or both.
Your profile is never submitted to a client organization without a specific conversation about the role, the company, and your interest. No surprise submissions, no volume approaches.
Opportunities are scoped against your specific life sciences regulatory experience, platform familiarity, and industry sector. We do not send pharmaceutical validation specialists to unrelated roles without a clear reason.
You will know where you stand at every stage. If we do not have something active that fits, we will tell you directly and stay in contact when the right opportunity emerges.
Contract and direct hire opportunities across pharmaceutical, biotech, medical device, and CDMO organizations. Active roles vary. Reach out to discuss what is current and relevant to your background.
Validation lifecycle ownership for SAP or Oracle platforms in pharmaceutical or biotech cGMP environments. IQ/OQ/PQ documentation, change control, inspection readiness.
Computer System Validation and Computer Software Assurance in life sciences manufacturing. GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA CSA 2022 Guidance environments.
GxP QMS ownership including CAPA, change control, document control, and deviation management in FDA-regulated pharmaceutical or biotech manufacturing.
SAP S/4HANA and SAP QM validation in life sciences manufacturing. IQ/OQ/PQ, GRC/audit trail compliance, and change-controlled upgrade support for pharmaceutical and biotech sites.
ERP implementation and CSV program oversight in pharmaceutical, biotech, and CDMO environments. Cross-functional QA/IT coordination, validation lifecycle scheduling, regulatory milestone management.
Compliant change management and remediation support for life sciences manufacturers under FDA Form 483 observations, warning letter, or pre-approval inspection preparation.
Contract placements are structured through an employer of record arrangement. Payroll, tax withholding, and benefits administration are handled through our EOR partner while you work on-site or remotely within the client organization.
Engagement durations vary based on client need, from a defined remediation program to a multi-year ERP validation effort. Rate expectations, structure, and timeline are discussed directly with you before any submission is made.
Tell us about your background in life sciences manufacturing validated systems. We will tell you honestly whether we have something active that fits and what the process looks like from here.