DeltaV SME | CQV Study Director | Pharma / Life SciencesThis Jobot Job is hosted by: Robert Donohue
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Salary: $120,000 - $140,000 per year
A bit about us:We are a global consulting and engineering firm supporting organizations across environmental compliance, infrastructure, and pharmaceutical development. With a strong presence worldwide, we partner with clients to deliver technical expertise, ensure regulatory compliance, and drive operational performance.
Our team supports complex validation and qualification efforts across regulated industries, helping clients bring systems and equipment online in a compliant and efficient manner.
We are looking for a DeltaV CQV Study Director to take ownership of validation studies and lead efforts from planning through final approval.
Why join us?- Health, Dental, and Vision insurance
- 401(k) with company match
- Life and Disability Insurance
- Paid Time Off, Holidays, and Vacation
Job DetailsWhat You'll Be Doing:
- Serve as the single point of accountability for CQV validation studies
- Own validation studies from protocol development through final approval
- Define validation scope and develop protocols, risk assessments, and documentation
- Coordinate approvals and ensure alignment with regulatory requirements
- Oversee execution of validation activities and ensure adherence to protocols
- Collaborate with Engineering, QA, QC, and Validation teams
- Manage change control, deviations, and validation investigations
- Ensure compliance with data integrity standards (ALCOA+)
- Review raw data for completeness, traceability, and accuracy
- Author validation summary reports and ensure successful study closeout
- Act as primary point of contact for QA Validation teams
What You Bring:
- Experience in CQV, validation, or qualification within a regulated industry (pharma preferred)
- Strong understanding of:
o Validation lifecycle
o Change control and deviation management
o Data integrity principles (ALCOA+)
- Experience working with DeltaV systems
- Ability to lead validation studies from start to finish
- Experience coordinating cross-functional teams
- Strong documentation and technical writing skills
- Familiarity with regulatory requirements and compliance standards
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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