Transdermal Operator III -Day Shift

Responsible for equipment start-up, participation in ANDA batch production, and commercial batch manufacturing. Expertise in transdermal mixing, coating, converting, packaging, and cartoning, with a focus on converting (die cutting) and troubleshooting.

Responsibilities

• Lead other operators during execution of batches and equipment qualifications.
• Execute the production schedule, ensuring equipment and material availability.
• Assist Supervisor with resolving issues, determining root cause, and providing solutions.
• Review and report potential issues that may impact batch execution to the department Supervisor.
• Monitor line for cGMP, SOP, or safety violations and report any factors impacting product safety, strength, or efficacy.
• Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities.
• Monitor automatic and semi-automatic equipment to manufacture transdermal products.
• Ensure accurate and prompt documentation of all processing equipment, room, scale, and environmental log books.
• Work with the Technical Writer to generate detailed equipment SOPs for set-up, operation, and cleaning.
• Monitor operator actions to ensure compliance during batch record execution.
• Execute commercial validation batches according to SOPs.
• Ensure 100% documentation accuracy on all GMP documents (e.g., batch records, log books, training records, in-process forms).
• Operate complex machines and SOPs for transdermal mixing, coating, converting, pouching, and cartoning operations.
• Set up, run, and clean equipment in a GMP-compliant environment.
• Support R&D and commercial scale-up activities.
• Train new personnel on SOPs and equipment qualifications.

Requirements

• High School diploma or GED (required).
• 5+ years of related experience in a manufacturing or GMP environment (required).
• Thorough understanding of processing equipment functionality and operational capabilities in the Transdermal Department.
• Strong expertise in converting (die cutting) and packaging.
• Successful completion of an OSHA-compliant Respirator Fit Test (required).

Skills

• Advanced proficiency in English (understanding and communication).
• Ability to perform repetitive tasks.
• Advanced math and mechanical skills.
• Advanced computer skills for data entry.
• Flexibility to work extended hours when required.

Schedule

Day Shift – 12-hour rotating schedule (6:00 AM – 6:30 PM): 3 days one week and 4 days the following week of the pay cycle, including every other weekend.

Pay

Hourly rate ranges from $27.00 to $35.00 per hour. Eligible for a short-term incentive opportunity (e.g., bonus or performance-based award) within the first 12 months.

Benefits

• Above-market, diverse, and robust health and insurance benefits.
• Significant 401(k) matching contribution for retirement savings.
• Programs promoting employee well-being to balance career and personal commitments.