About this opportunity
KVK Tech, Inc. lists this Technical Services Manager opportunity in newtown, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
Job description
KVK Tech is seeking a Technical Services Manager to join our team in Newtown, PA.
The Technical Services Manager will lead a team responsible for process validation, technical transfer, and GMP documentation supporting oral solid dosage manufacturing and packaging operations. This role ensures all technical documentation, process validation, and change control activities are executed to the highest standards of data integrity, efficiency, and regulatory compliance. The ideal candidate will bring extensive experience in technical services and validation within the pharmaceutical industry, with a proven track record of managing teams, documentation systems, and cross‑functional initiatives.
Responsibilities
Lead the preparation, review, and approval of technical documentation including validation protocols/reports, master batch records, SOPs, and technical transfer dossiers in accordance with cGMP requirements.
Oversee process validation and technical transfer activities for oral solid dosage manufacturing, ensuring robust documentation and regulatory alignment.
Manage change control activities related to manufacturing, packaging, and engineering systems, ensuring thorough impact assessment and timely execution.
Provide leadership, coaching, and development to Technical Services staff to ensure high‑quality deliverables and balanced workload distribution.
Collaborate cross‑functionally with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and R&D to resolve technical issues and maintain documentation readiness.
Drive continuous improvement initiatives to strengthen data integrity, streamline documentation workflows, and enhance departmental efficiency.
Qualifications
Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline required; Master’s degree preferred.
8–10 years of progressive experience in technical services, process validation, documentation, or manufacturing support within an oral solid dosage pharmaceutical environment.
Minimum 3–5 years of leadership or supervisory experience managing technical or documentation‑focused teams.
Strong understanding of process validation, technical transfer, and change control systems in compliance with FDA, ICH, and USP standards.
Proven technical writing and documentation management skills with a focus on clarity, accuracy, and compliance.
Familiarity with document control systems (e.g., MasterControl) and data integrity expectations under cGMP.
Excellent organizational, communication, and project management abilities, with the capacity to lead cross‑functional initiatives.
Certifications in Lean, Six Sigma, or Project Management preferred.
Benefits
401(k) with company match
Health, vision, and dental Insurance
Childcare expense reimbursement
Tuition reimbursement
Annual bonus eligibility
Annual merit increases
Paid Time Off and Flexible Holidays
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
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Worksite address
newtown, PA, 18940, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.