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 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 minimal 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.

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Proficient in execution and knowledge of aseptic techniques.
• Prepares solutions, conducts filtrations, and performs aseptic filling and labeling of vials/syringes under cleanroom, non-sterile conditions.
• Assembles, disassembles and operates aseptic filling equipment in classified cleanroom and controlled non classified environments.
• Loads and unloads product from liquid fill line.
• Prepares equipment and components for liquid fill line.
• Operates processing equipment including filter integrity tester, filling isolators, peristaltic pumps, balances, and other GMP equipment.
• Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs.
• Sanitizes production areas and completes line clearance of liquid fill lines.
• Completes and maintains 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 per GMP requirements.
• 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.
• Reviews and revises pertinent SOPs and production batch records as required.
• Successfully participates in media fill/aseptic proficiency tests.

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.

• 2-4 years of relatable experience, preferably in a pharmaceutical manufacturing environment or in the medical device industry. Fill finish experience, preferred.
• Requires AA degree with 0-2 years' experience or high school diploma with 1-3 years related manufacturing experience.
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familiar context.

• Preferred:

• Ability to demonstrate attention to detail.
• Ability to display excellent time management skills.
• Ability to work independently and/or as part of a team.
• Experience in Sterile Fill and Finish CGMP environment
• Experience in a cleanroom environment with PPE
• Experience with visual inspection of drug products
• Experience working in an FDA regulated industry

The base salary range for this position is $20.00 to $21.00 per hour plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

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.