Compression Operator (3:00pm-11:30pm; Compression Exp. Required)

Job Description

Job Description

Compression Operator (2nd Shift)

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 Compression Operator is responsible for independently setting up, operating, and monitoring tablet compression equipment used in the production of oral solid dosage pharmaceutical products. This position plays a key role in ensuring consistent product quality, efficiency, and compliance with cGMP and FDA standards. The role also supports training of junior operators, assists in process improvements, and contributes to maintaining a clean, safe, and inspection-ready manufacturing environment.

Key Responsibilities:

• Independently set up, operate, and monitor tablet compression equipment and associated ancillary systems per approved batch records and SOPs.
• Perform in-process testing (e.g., tablet weight, hardness, thickness, and appearance) and make machine adjustments within defined parameters to maintain product quality.
• Conduct equipment cleaning and changeover activities in compliance with validated cleaning procedures and documentation requirements.
• Complete accurate, legible, and contemporaneous entries in batch records, logbooks, and electronic systems consistent with data integrity principles (ALCOA+).
• Inspect materials and equipment before and during use to verify cleanliness and readiness for production.
• Identify and escalate equipment malfunctions, product deviations, or out-of-specification results to supervision and Quality Assurance.
• Collaborate with QA during in-process checks, line clearances, and deviation investigations to ensure compliance and documentation accuracy.
• Provide on-the-job training and functional guidance to Manufacturing Operator I personnel as assigned.
• Participate in cross-training across other manufacturing processes (e.g., blending, encapsulation, coating) to support production flexibility and coverage.
• Recommend process improvements related to safety, efficiency, and product quality.
• Follow all company safety procedures and maintain good housekeeping practices in compliance with 5S standards.
• Perform other duties as required to support Manufacturing operations.

What We’re Looking For

Experience: Minimum 1–5 years of pharmaceutical manufacturing experience, preferably in tablet compression, with demonstrated proficiency in at least one or more manufacturing processes.

Education: High school diploma or equivalent required; technical training or certification in manufacturing or mechanical systems preferred.

Skills & Knowledge:
• Proficient in cGMP operations and FDA documentation requirements.
• Strong mechanical aptitude and ability to perform equipment setup, operation, and minor troubleshooting.
• Skilled in performing in-process testing and interpreting results to maintain control of compression operations.
• Attention to detail with commitment to accuracy, data integrity, and Good Documentation Practices (GDP).
• Ability to train and mentor less experienced operators in proper techniques and documentation.
• Excellent organizational and communication skills in a fast-paced production environment.
• Strong commitment to safety, teamwork, and continuous improvement.

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 evening-shift position. Flexibility required for overtime, weekend coverage, or alternate shifts based on production schedules.

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 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.