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Bedford, Massachusetts, United States
Onsite
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.
Summary of Objective:
The Manufacturing Technician 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.
*Hiring multiple levels based on experience*
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
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.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
This is an individual contributor role.
TRAVEL – <10%
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: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.
#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.
