Energy Jobline ZR
Technical Services Manager (OSD Pharmaceutical Experience Req.) in Newtown
Energy Jobline ZR, Newtown, Connecticut, us, 06470
Manager, Technical Services
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 Manager, Technical Services leads the creation, review, and maintenance of technical documentation and process validation activities supporting KVK Tech’s oral solid dosage manufacturing and packaging operations. This role ensures the successful execution of technical transfer, change control, and process validation programs while maintaining full cGMP and regulatory compliance. The Manager provides leadership and direction to the Technical Services team, fostering collaboration across Manufacturing, Quality, Engineering, Regulatory Affairs, and R&D to drive operational readiness, data integrity, and continuous improvement across technical processes. Key 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. What We’re Looking For
Experience
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. Education
Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related discipline required; Master’s degree preferred. Skills & Knowledge
In‑depth knowledge of pharmaceutical manufacturing processes, process validation, and change control in a cGMP‑regulated environment. Strong technical writing and documentation management skills with a focus on clarity, accuracy, and regulatory compliance. Demonstrated leadership in managing cross‑functional technical teams and documentation workflows. Proficiency in electronic document management systems (e.g., MasterControl) and data integrity principles. Excellent organizational, project management, and problem‑solving abilities with a continuous improvement mindset. Effective communication and interpersonal skills, with the ability to engage across departments and with senior leadership. Familiarity with FDA, ICH, and USP regulatory frameworks governing oral solid dosage manufacturing. Certification or training in Lean, Six Sigma, or Quality Risk Management methodologies. 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 with standard business hours (Monday through Friday, 8:00 a.m. – 5:00 p.m.). Flexibility required for extended hours during validation, documentation, or regulatory submission activities.
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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 Manager, Technical Services leads the creation, review, and maintenance of technical documentation and process validation activities supporting KVK Tech’s oral solid dosage manufacturing and packaging operations. This role ensures the successful execution of technical transfer, change control, and process validation programs while maintaining full cGMP and regulatory compliance. The Manager provides leadership and direction to the Technical Services team, fostering collaboration across Manufacturing, Quality, Engineering, Regulatory Affairs, and R&D to drive operational readiness, data integrity, and continuous improvement across technical processes. Key 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. What We’re Looking For
Experience
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. Education
Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related discipline required; Master’s degree preferred. Skills & Knowledge
In‑depth knowledge of pharmaceutical manufacturing processes, process validation, and change control in a cGMP‑regulated environment. Strong technical writing and documentation management skills with a focus on clarity, accuracy, and regulatory compliance. Demonstrated leadership in managing cross‑functional technical teams and documentation workflows. Proficiency in electronic document management systems (e.g., MasterControl) and data integrity principles. Excellent organizational, project management, and problem‑solving abilities with a continuous improvement mindset. Effective communication and interpersonal skills, with the ability to engage across departments and with senior leadership. Familiarity with FDA, ICH, and USP regulatory frameworks governing oral solid dosage manufacturing. Certification or training in Lean, Six Sigma, or Quality Risk Management methodologies. 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 with standard business hours (Monday through Friday, 8:00 a.m. – 5:00 p.m.). Flexibility required for extended hours during validation, documentation, or regulatory submission activities.
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