Manufacturing Technician I, M-F 6AM to 2:30 PM, Manchester site

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Sur place; USD 25 000 - 39 000; Plein temps

Résumé du poste

PCI Pharma Services is seeking a Manufacturing Technician I to join our sterile and aseptic production teams in New Hampshire. Under supervision, you will perform routine and critical manufacturing operations, including aseptic compounding, filling, equipment prep, and lyophilization per GMP/ISO standards.

You will work closely with Master Production Records, SOPs, and quality systems, maintaining safety, accuracy, and documentation while supporting continuous manufacturing improvements.

Qualifications

• 0–2 years of manufacturing experience, preferably pharma or medical devices.
• High school diploma or equivalent required.
• Able to weigh and measure raw materials and operate benchtop instruments.
• Follow written instructions and seek help for non-routine tasks as needed.
• Strong attention to detail and commitment to safety and ethics.

Responsabilités

• Maintain safe work habits and follow PCI safety procedures.
• Prepare solutions, aseptic filling, and labeling under sterile/non-sterile conditions.
• Operate aseptic filling equipment and lyophilizer in cleanrooms.
• Prepare equipment for sterilization and lyophilization.
• Perform COP, CIP, and SIP operations for manufacturing readiness.
• Document work in logbooks and batch records with accuracy.
• Identify deviations, escalate issues, and assist investigations.
• Maintain cleanliness and order in production areas.
• Review SOPs and production batch records as required.
• Contribute to a positive PCI culture and participate in media fills.

Connaissances

Attention to detail

Mechanical aptitude

Good verbal and written skills

Self-starter

Follow written instructions

weigh and measure raw materials

Formation

High school diploma or equivalent

Outils

Benchtop instruments

Description du poste

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Technician I learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of PCI. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products. Works with Master production records and standard operating procedures. Conducts self in accordance with the Guardian values and behaviors.

Essential Duties and Responsibilities:

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Demonstrates general knowledge 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 prepares equipment for production.
• Completes and maintain documentation related to assigned work, including logbooks, batch records, etc.
• 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; participate as needed in investigations.
• Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs.
• Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Reviews and revises pertinent SOPs and production batch records as required.
• 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

Special Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
• Ability to gown and gain entry to controlled manufacturing areas.
• Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.
• Ability to stand for 6 hours in a production suite.
• Ability to work any shift (up to 10 hours) as required dependent on business needs.

Qualifications:

• 0 – 2 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry.
• Minimum of a High school diploma/equivalency.
• Ability to weigh and measure raw materials and operate basic Benchtop instruments.
• Able to follow written instructions.
• Seeks help with more complex and non-routine tasks.
• Good verbal and written skills Pay attention to detail.
• Demonstrates a good mechanical aptitude.
• Commits 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.
• Honesty, integrity, respect and courtesy with leadership and peers
• Openly receives and implements feedback, resilient, able to move past mistakes; applies learning.
• Self-starter, able to work in a fast dynamic work setting #LI-LL1

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future