Senior Manufacturing Lead — Biopharma Operations

PCI Pharma Services; Bedford (NH); On-site; USD 60,000 - 85,000; Full time

Job summary

PCI Pharma Services in New Hampshire is seeking a Manufacturing Technician III/IV to lead a team through aseptic fill/finish operations in a GMP environment. You will prepare solutions, operate filling and lyophilization equipment, and ensure compliance with SOPs, MBRs and safety guidelines.

The role requires 2–4 years in pharma or medical devices, strong aseptic skills, attention to detail, and the ability to train others.

Qualifications

• 2 - 4 years in the pharmaceutical or medical device industry finished dose form preferred.
• Strong knowledge of aseptic techniques and fill finish experience required.
• Experience in reviewing and creating controlled documents.
• Possesses the skill and aptitude to weigh and measure raw materials and operate basic Benchtop instruments.
• Strong ability to plan and prioritize complex activities to meet goals and objectives.
• Strong analytical skills to identify risks and prepare balanced decision.
• Excellent organizational, verbal and written communication skills.
• Detail oriented with strong mechanical aptitude.
• Positive attitude and strong interpersonal skills to resolve and de-escalate issues.
• Honesty, integrity, respect and courtesy with leadership and peers.
• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services.
• Resilient, can quickly move forward despite complexities and unexpected events, thrives on challenges to improve skills and abilities.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.

Responsibilities

• Leads team to successfully and completely accomplish daily tasks.
• Maintains weekly/daily schedule up to date and provides direction to team.
• Accountable for completing daily tasks and reporting and escalating issues to management.
• Works with management to provide a positive culture within operations.
• Mentors less experienced staff in the performance of aseptic techniques.
• Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization.
• Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments.
• Operates vial capper, unloads product from lyophilizers and liquid fill line.
• Prepares equipment and components for sterilization and Lyophilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.
• Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs.
• Sanitizes production areas and prepare equipment for production.
• Completes, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc.
• Trains others on the team, and ensures proper training completion within the team prior to assigning tasks.
• Troubleshoot and resolve problems with equipment or processes in the course of performing job duties.
• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
• Identifies, escalates and documents events that deviate from normal operation; perform investigations as needed.
• Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs.
• Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Demonstrated understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations
• Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients.
• Successfully participates in media fill/aseptic proficiency test.

Skills

Aseptic techniques

Leadership

Troubleshooting

Documentation

Safety compliance

Training others

Attention to detail

Communication skills

Self-starter

Education

High school diploma

Job description

PCI Pharma Services in New Hampshire is seeking a Manufacturing Technician III/IV to lead a team through aseptic fill/finish operations in a GMP environment. You will prepare solutions, operate filling and lyophilization equipment, and ensure compliance with SOPs, MBRs and safety guidelines.

The role requires 2–4 years in pharma or medical devices, strong aseptic skills, attention to detail, and the ability to train others.