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.

JOB SUMMARY

The Manufacturing Technician II proficiently performs a variety of complex tasks under general guidance 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.

JOB DUTIES –

Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines Proficient execution and 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 prepare 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 LSNE 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

PROFESSIONAL SKILLS -

• Ability to weigh and measure raw materials and operate basic Benchtop instruments (move to physical?)
• Able to follow written instructions.  Seeks help with more complex and non-routine tasks
• Skilled at organizing and prioritizing assigned tasks to assure completion
• Can translate ideas on how to improve work tasks
• Strong verbal and written skills

 EXPERIENCE –

• 2 -4 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical  or medical device industry.  Fill finish experience, preferred.

EDUCATION –

• Requires AA degree with 0-2 years’ experience or high school diploma with 1-3 years related manufacturing experience or Associates Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Biotech Certificate and 1 year of experience

QUALITIES –

• Attention to detail with good mechanical aptitude
• Good attitude and good interpersonal skills
• Honesty, integrity, respect and courtesy with leadership and peers 
• Demonstrates a 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 
• Resiliency, the ability to move forward despite mistakes, with a sincere desire to improve
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

PHYSICAL REQUIREMENTS –

• 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

COMMUNICATIONS & CONTACTS –

• Interacts with