Manufacturing Technician I/II/III Sun-Wed 3:30 PM to 2AM

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Sur place; USD 42 000 - 64 000; Plein temps

Résumé du poste

PCI Pharma Services in Bedford, NH is hiring a Manufacturing Technician I to perform aseptic filling, solution prep, and labeling under GMP/ISO guidelines. You will operate sterile equipment, maintain cleanroom conditions, and document batch records with supervision.

The role requires 0–2 years of experience and a high school diploma, with potential shift work and emphasis on safety and accuracy. The position supports the production of biopharma and medical device products, involves PPE use, and

Qualifications

• 0–2 years of working experience in manufacturing, preferably pharma or medical devices.
• Minimum high school diploma or equivalent.
• Ability to weigh and measure raw materials and operate basic benchtop instruments.
• Follow written instructions with attention to detail.

Responsabilités

• Maintains safe work habits and follows PCI safety procedures.
• Performs aseptic filling, labeling, and solution preparation under sterile conditions.
• Operates aseptic filling and lyophilizer equipment in cleanrooms.
• Prepares equipment for sterilization and lyophilization; documents batch records.

Connaissances

Aseptic techniques

Verbal and written skills

Mechanical aptitude

Self-starter

Formation

High school diploma/equivalency

Outils

Benchtop instruments

Autoclaves

Lyophilizer equipment

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.

Special Demands

• 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.

SPECIAL NOTE: While the PCI Mfg. Technician roles are essentially the same at all company pharmaceutical manufacturing sites, presently at 25 Commerce Drive Bedford, the extensive product mix creates a highly dynamic, complex and at times a challenging work environment. Thus, operators are expected to be highly resilient and possess the following skills an attributes: Ability to adapt to a changing process daily (i.e., Formulations vary depending on client product) Able to work under the scrutiny of clients daily Expected to be flexible with the process and adjust work hours accordingly.

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

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

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.