Job Information
PCI Pharma Services MANUFACTURING TECHNICIAN I in Madison, Wisconsin
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 Description
JOB SUMMARY
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.
JOB DUTIES –
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 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 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
PROFESSIONAL SKILLS -
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 written and verbal skills
EXPERIENCE –
- 0 – 2 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry.
EDUCATION –
- Minimum of a High school diploma/equivalency.
QUALITIES –
Pays 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
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 cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES -
- This is an individual contributor role
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
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.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
PCI Pharma Services
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