Manufacturing Technician II

Job Title:

Level II Production Operator (Technician II)

Responsibilities:

• Execute and run autonomously batch aseptic manufacturing activities, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with AEMPS, FDA, and other regulatory agencies under supervision.
• Ensure execution of production plans and compliance with company safety guidelines.
• Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs.
• Work as a team, being approachable, practical, motivating, and able to support and inspire co-workers.
• Comply with schedule by following the prioritization instructions of senior managers and ensuring compliance with schedules together with the department head.
• Collaborate in identification of opportunities for continuous improvement to improve processes and practices.
• Comply with cGMP, AEMPS, FDA and other regulatory agencies, as well as department objectives and corporate quality standards.
• Participate in preparing for inspections by regulatory agencies or clients.
• Control the stock of plant consumables, guaranteeing availability.
• Investigate quality events such as deviations, CAPAs, change controls.
• Inform direct manager when anomalies are detected in operation of equipment or human errors, ensuring product quality.
• Inform direct manager if safety equipment or human resources needs are identified.
• Collaborate with other departments if required.
• Maintain proper functioning of equipment and operate production equipment following guidelines.
• Participate in manufacture of products following manufacturing guides and cGMP regulations.
• Operate pallet trucks for movement of goods.
• Review relevant SOPs and production lot records as needed.
• Complete and maintain documentation related to assigned work, including notebooks, batch records, etc.
• Maintain cleanliness and order of production areas per SOP.
• Support activities of qualification of production equipment.
• Demonstrate general knowledge of aseptic techniques.
• Participate in gowning qualification and media fill plan.
• Lead activities of dispensing and preparing materials, sanitization of materials, disinfecting clean production rooms.
• Lead or support setup of grade D/C, grade A/B; formulation processes grade C and A/B; filtration processes grade C and AB; filling activities; sterilizable equipment execution.
• Train technicians Level I.

Minimum qualifications:

• Minimum training time of 3 years to develop full work competence.

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose:
Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.