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 IV - Lead leads others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety guidelines of PCI. With general supervision, the technician leads and performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products. Addresses non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel.
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. Is proactive in identifying safety risks and alerts management to take corrective action.
- Leads team to accomplish daily tasks
- Maintains weekly/daily schedule up to date and provides direction to team
- Accountable for completing daily tasks and reporting issues to management
- Works with management to provide a positive culture within operations
- Mentors less experienced staff in the performance 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, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc.
- Trains and ensures proper training within the team prior to assigning tasks
- Troubleshoot and resolve problems with equipment or processes in the course of performing job duties
- 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; perform investigations as needed
- Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
- Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
- Demonstrated understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations
- 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.
- Exceptional organizational skills and attention to detail
- Excellent interpersonal skills
- Proficiency in MS Office including Word, and Excel
- Ability to work in a dynamic, fast paced work environment
- Honesty, integrity, respect and courtesy with all colleagues
- Creative with the ability to work with minimal supervision and balanced with independent thinking
- Resilient through operational and organizational change
- Ability to weigh and measure raw materials and operate basic enchtop instruments
- Strong ability to plan and prioritize complex activities to meet goals and objectives
- Strong analytical skills to identify risks and prepare balanced decisions
- Excellent organizational, verbal and written communication skills
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.
- 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 need
- Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
- Leads team of manufacturing technicians to complete scheduled activities
- Raise any personnel related issues to management for resolution
- Assigns daily tasks
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.
- Requires a high school diploma with 4+ years of cGMP Pharmaceutical experience to include finished dose form
- 4+ years of working experience in the pharmaceutical or medical device industry.
- Strong knowledge of aseptic techniques and fill finish experience required
- Experience in reviewing and creating controlled documents
- Detail oriented with strong mechanical aptitude
- Positive attitude and strong interpersonal skills to resolve and de-escalate issues.
- Honesty, integrity, respect and courtesy with leadership and peers
- Strong 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
- Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
- Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
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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.
