Manufacturing Technician I​/II​/III - Weds - Sat

Position: Manufacturing Technician I/II/III - Weds - Sat 3:30PM - 2:00AM
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.Join us and be part of building the bridge between life changing therapies and patients.
** 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.*###
** Summary of Objective:
** 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.
** Shift:
** Weds - Sat 3:30PM - 2:00AM
*
* 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…