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This role is responsible for engineering and technical oversight of the equipment and facilities of the Sterile Fill & Finish (SFF) implementation project(s) in San Diego. This person will become the technical Subject Matter Expert (SME) for the Cytiva isolator filling technology implemented in San Diego as well as the associated processing equipment related to formulation and sterile filling. This position will define relevant operational/technical standards and practices for the San Diego SFF operation and identify and drive the implementation of improvements to maximize throughput and capacity utilization. The role will interface with other PCI functions as well as external clients to implement new sterile filling projects and technologies into PCI GMP manufacturing. Responsible for the generation and execution of validation protocols, assistance in audits, determination of validation needs, and training of SFF staff.

• Provide technical support to GMP operations in a multi-product Sterile fill/finish and solid oral dose pharmaceutical manufacturing facility.

• Ability to author production and technical documents.

• Provide engineering study and start up start-up or tech transfer projects, including preparation of document templates, participation and overs, eight of testing, and lead engineering program management activities for such projects.

• Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.

• Provides technical support and analysis for the resolution of deviations, investigations, and price, issues.

• Complete technical investigations and provides technical support.

• Support manufacturing in the investigation of deviations and performs required risk assessments.

• Identify, own and resolve process and equip equipment-related proactively. Support the proposal, initiation, testing, and, implementation of minor proposed changes to equipment and/or production processes.

• Generate technical and production documents (technical memos and reports, protocols, etc.,) related to process non-conformances.

• Participate in the review of processes to achieve cost cost-effectiveness and improved product quality.

• Provide troubleshooting expertise for manufacturing of products both internally and externally of the company.

Requirements:

• Bachelor's Degree in a related field and/or 1-3 years of related d experience and/or training.

• College Level Mathematical Skills

• Experience with the installation and operation of complex and/or robotic manufacturing equipment.

• Ability to work on multiple projects at the same time

• Ability to meet aggressive timelines

• Good interpersonal/teamwork skills

• Effective communication skills (verbal and written form)

• Good documentation practices

• Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, SPC software, and Microsoft PowerPoint

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred:

• Aseptic Filling or Robotic Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices.

• Cleanroom/HVAC/Utility/Facilities Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and high understanding of heating, air conditioning, and refrigeration systems.

• Computer Validation Focus: Ability to perform highly complex computer tasks and have experience with computer systems considered to have an impact on cGMP, and PCI guidelines.

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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.