Manufacturing Group Lead (1st & 2nd Shift)

KVK Tech is seeking an experienced Manufacturing Group Lead to join our team in Newtown, PA.

The Manufacturing Group Lead serves as a hands-on, working lead responsible for supporting daily oral solid dosage manufacturing operations across areas such as weighing, blending, compression, coating, encapsulation, and related processes. This role provides rotating room coverage, directs floor execution during active operations, and independently operates manufacturing equipment as needed to support production goals. The ideal candidate will demonstrate strong technical knowledge of oral solid dosage manufacturing, a solid understanding of cGMP requirements and Good Documentation Practices, and the ability to coach operators while maintaining safe, efficient, and compliant operations.

This position’s responsibilities will include, but not be limited to the following:

• Set up, operate, monitor, and troubleshoot oral solid dosage manufacturing equipment, including compression, encapsulation, weighing/blending, coating, and fluid bed drying systems, in accordance with approved batch records and SOPs.
• Provide rotating room leadership during active operations by directing workflow, monitoring operator execution, and reinforcing adherence to batch instructions, safety requirements, and cGMP standards.
• Perform and verify in-process checks, support line clearance activities, and help oversee equipment cleaning, changeovers, and room readiness to ensure compliant and efficient manufacturing execution.
• Train and coach manufacturing operators in equipment operation, documentation practices, gowning, line clearance, and safe material handling while reinforcing strong floor discipline and compliance expectations.
• Review batch records, equipment logbooks, and related production documentation for completeness, legibility, accuracy, and compliance with Good Documentation Practices.

We are looking for applicants with:

• High school diploma or equivalent required; technical school training or coursework in manufacturing or a related field preferred.
• Minimum 5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment required; candidates with 3–4 years of directly relevant experience may be considered if they demonstrate strong technical capability across multiple OSD processes and prior lead coverage experience.
• Hands-on experience with oral solid dosage manufacturing operations such as weighing, blending, compression, coating, encapsulation, and equipment changeovers strongly preferred.
• Advanced operational knowledge of multiple oral solid dosage manufacturing processes and related equipment.
• Strong understanding of cGMP requirements, FDA expectations, Good Documentation Practices, and data integrity principles.
• Strong attention to detail, problem-solving ability, and the ability to provide effective floor leadership and operator coaching in a working lead capacity.
• Effective written and verbal communication skills and ability to collaborate cross-functionally.

What we offer:

• 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.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.