Technical Services Lead, Validation & Documentation

KVK Tech, Inc.; Pennsylvania; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) match

Medical, dental, vision, life

Career growth opportunities

Tuition reimbursement

Childcare expense reimbursement

Job summary

KVK Tech, Inc. seeks a Technical Services Manager to lead the technical services function for oral solid dosage operations. You will oversee documentation, validation, transfer, and change control, partnering with Manufacturing, Engineering, QA, Regulatory, and R&D to ensure compliant, efficient processes.

You will manage a Technical Services team, drive continuous improvement, and ensure data integrity and regulatory readiness across audits and submissions.

Qualifications

• 8–10 years in technical services, process validation, or manufacturing support within an oral solid dosage pharmaceutical environment.
• 3–5 years of leadership or supervisory experience managing technical staff and documentation-related functions.
• Experience with process validation, technical transfer, deviation/CAPA documentation, and regulatory compliance in a cGMP setting.

Responsibilities

• Lead preparation, review, approval, and maintenance of technical documentation, including SOPs, batch records, validation protocols and reports, master records, and technical transfer packages.
• Oversee process validation, cleaning validation, technical transfer, and change control activities to support commercial manufacturing, scale-up, and process improvements.
• Partner cross-functionally with Manufacturing, Engineering, QA, Regulatory, and R&D to resolve technical issues, support investigations, and ensure documentation readiness.
• Manage and mentor the Technical Services team, including assigning priorities, monitoring deliverables, balancing workloads, and supporting employee development.
• Drive continuous improvement to documentation workflows, reduce cycle times, strengthen compliance, and support operational efficiency.
• Ensure document control integrity, data integrity, and adherence to cGMP, FDA, ICH, USP, and internal quality standards.
• Serve as a departmental subject matter expert during audits, inspections, regulatory submissions, and cross-functional project activities.
• Coordinate validation-related activities for process, equipment, and cleaning validation programs to support product quality, compliance, and inspection readiness.

Skills

Process validation

Technical transfer

Change control

Documentation

Technical writing

Cross-functional collaboration

Education

Chemical Engineering

Pharmaceutical Sciences

Chemistry

Tools

EDMS

Document control

Job description

KVK Tech, Inc. seeks a Technical Services Manager to lead the technical services function for oral solid dosage operations. You will oversee documentation, validation, transfer, and change control, partnering with Manufacturing, Engineering, QA, Regulatory, and R&D to ensure compliant, efficient processes.

You will manage a Technical Services team, drive continuous improvement, and ensure data integrity and regulatory readiness across audits and submissions.