Technical Services Manager (Oral Solid Pharma Manufacturing Exp. Req.) in Newtown

Job DescriptionJob Description

About KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

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.
• Master’s degree .

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
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)

Company Description

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.