Manufacturing Technician IV - Lead M-F

Overview

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. PCI focuses on people who make an impact, drive progress and create a better tomorrow. The Manufacturing Technician IV - Lead leads others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety guidelines of PCI.

With general supervision, the technician leads and performs all manufacturing operations including equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products.

• Lead team to accomplish daily tasks; maintain weekly/daily schedule and provide direction to the team.
• Accountable for completing daily tasks and reporting issues to management; work with management to foster a positive culture within operations.
• Train and mentor less experienced staff in aseptic techniques.
• Prepare solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions; routine solution and filtration; vial and component preparation and sterilization.
• Assemble, disassemble and operate aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled environments.
• Operate vial capper; unload product from lyophilizers and the liquid fill line.
• Prepare equipment and components for sterilization and Lyophilization; operate processing equipment including autoclaves, ovens, vial washers, depyrogenation, centrifuges, and mills equipment.
• Assist in formulation and dispensing of product in a clean room environment per SOPs and MBRs; sanitize production areas and prepare equipment for production.
• Complete, maintain and review documentation related to assigned work (logbooks, batch records, etc.).
• Troubleshoot and resolve equipment or process issues; adhere to verbal instructions and written procedures; accurately complete production documentation.
• Identify, escalate and document events that deviate from normal operation; perform investigations as needed.
• Maintain compliance, cleanliness and orderliness of operational areas per SOPs; perform COP, CIP, and SIP operations to prepare equipment for manufacturing.
• Demonstrate understanding of sanitization and sterilization practices to build, clean and sterilize equipment to support production operations.
• Contribute to a culture of safety and continuous improvement; participate in media fill/aseptic proficiency tests as required.

• Physically capable to perform duties with or without reasonable accommodations; exceptional organizational skills and attention to detail.
• Proficiency in MS Office (Word, Excel); ability to work in a dynamic, fast-paced environment; honesty, integrity, respect and courtesy in interactions.
• Creative with minimal supervision and independent thinking; resilient through change; able to weigh and measure raw materials and operate basic bench-top instruments.
• Strong planning and prioritization; strong analytical, verbal and written communication skills; ability to handle multiple priorities in a cross-functional team.

• Ability to wear PPE (safety glasses/goggles, gloves, safety shoes) and gown for controlled manufacturing areas.
• Ability to lift, pull or push up to 25-50 lbs; stand for extended periods; work any shift (up to 10 hours) as required by business need.
• Ability to read, understand, and follow technical documents (SOPs) written in English; effective communication in speech, vision, hearing and written form.
• Interacts with cross-functional teams (Operations, QA, QC, Engineering, R&D, Validation, etc.).

• High school diploma with 4+ years of cGMP pharmaceutical experience to include finished dose form; 4+ years of experience in pharmaceutical or medical device industry.
• Strong knowledge of aseptic techniques and fill-finish experience; experience in reviewing and creating controlled documents.
• Detail-oriented with strong mechanical aptitude; positive attitude and interpersonal skills to resolve and de-escalate issues.
• Commitment to PCI standards of honesty, integrity, and ethical conduct; resilience and ability to move forward through challenges.
• Ability to work as a self-starter and manage multiple priorities in a dynamic cross-functional team.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not 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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. We are committed to an inclusive workplace and equal opportunity for all employees and applicants.