Technical Services Manager

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

The Technical Services Manager is responsible for leading the Technical Services function in support of oral solid dosage manufacturing and packaging operations. This role oversees the development, review, approval, and maintenance of critical technical documentation, including batch records, validation protocols and reports, SOPs, and technical transfer documentation. The Technical Services Manager serves as a key cross-functional leader, partnering with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and R&D to support process validation, cleaning validation, technical transfer, change control, and continuous improvement initiatives. This position also provides direct leadership to Technical Services personnel, ensuring high-quality deliverables, strong documentation practices, and alignment with regulatory and business requirements.

Key Responsibilities:

• Lead the 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 efforts, and ongoing process improvements.
• Partner cross-functionally with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, 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 initiatives that enhance documentation workflows, reduce cycle times, strengthen compliance, and support operational efficiency.
• Ensure document control integrity, data integrity compliance, 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 associated with process, equipment, and cleaning validation programs to support product quality, compliance, and inspection readiness.

What We’re Looking For

Experience:

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

Education:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline required.

Skills & Knowledge:

• Strong understanding of oral solid dosage manufacturing, process validation principles, technical transfer, and change control systems.
• Proven technical writing and document review experience involving SOPs, protocols, reports, batch records, and related GMP documentation.
• Experience with electronic document management systems, document control practices, and data integrity expectations.
• Strong organizational, project management, and prioritization skills with the ability to manage multiple concurrent initiatives.
• Excellent written and verbal communication skills with the ability to work effectively across departments and with senior leadership.
• Lean Six Sigma, Quality Risk Management, Validation, or Project Management certifications are a plus.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Comprehensive medical, dental, vision, and life insurance coverage
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement