KVK Tech, Inc. · 1 month ago
Technical Services Manager (Oral Solid Pharma Manufacturing Exp. Req.)
Newtown, PA, US
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKVK Tech, Inc. is a U.S.-based generic and specialty pharmaceutical manufacturer dedicated to producing high-quality, FDA-approved medicines. The Manager, Technical Services will lead the creation and maintenance of technical documentation and process validation activities for oral solid dosage manufacturing, ensuring compliance with cGMP standards and fostering collaboration across various departments.
ManufacturingMedical DevicePharmaceutical
Responsibilities
Lead the preparation, review, and approval of all Technical Services documentation, including batch records, validation protocols/reports, SOPs, and technical transfer dossiers in compliance with cGMP standards
Oversee process validation and technical transfer activities for oral solid dosage manufacturing, ensuring data integrity, scientific soundness, and adherence to FDA, ICH, and USP guidance
Manage the change control process for manufacturing, packaging, and engineering systems, ensuring appropriate impact assessments, approvals, implementation, and closure
Direct and mentor Technical Services staff, providing training, workload oversight, and professional development to sustain a high-performing and compliant team
Collaborate cross-functionally to resolve technical issues, support investigations, and ensure documentation readiness for product release and regulatory submissions
Provide technical authorship and oversight for deviations, CAPAs, and investigations, ensuring documentation accuracy and timely closure
Support Regulatory Affairs in the preparation and submission of technical documentation for ANDAs, post-approval changes, and responses to regulatory inquiries
Establish and maintain departmental KPIs and dashboards to monitor documentation cycle times, change control closure rates, and validation progress
Participate in internal and external audits and inspections, serving as a subject-matter expert for Technical Services
Maintain the integrity of the document management system (e.g., MasterControl), ensuring accurate version control, archival, and accessibility of controlled documents
Coordinate with Validation, Facilities, and Manufacturing to evaluate equipment or process modifications and ensure appropriate qualification or revalidation
Identify and implement continuous improvement initiatives to streamline documentation workflows, enhance compliance, and increase departmental efficiency
Ensure all Technical Services operations align with corporate data integrity, documentation, and change management policies
Perform additional duties as assigned to support departmental and organizational objectives
Qualification
Required
Minimum 8–10 years of progressive experience in technical services, process validation, documentation management, or manufacturing support within an oral solid dosage pharmaceutical environment, including 3–5 years in a leadership or supervisory capacity
Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related discipline required
Preferred
Master's degree preferred
Benefits
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
Company
KVK Tech, Inc.
KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs.
501-1000 employees
H1B Sponsorship
KVK Tech, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (18)
2023 (15)
2022 (27)
2021 (27)
2020 (28)
Funding
Current Stage
Late StageLeadership Team
A
Anthony Tabasso
President and CEO
Recent News
2026-01-01
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