Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Aseptic Manufacturing Technician II (Night Shift)
300 Rouse Boulevard Philadelphia, PA 19112 US
Posted: 01/14/2025
2025-01-14
2025-02-15
Employment Type:
Contract
Job Category: Scientific
Job Number: 616270
Is job remote?: No
Country: United States
Job Description
Overview
The Aseptic Manufacturing Technician II role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Manufacturing Technician will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work on weekends and holidays.
Shifts: A or B
Shift A-Rotation
• Week 1
o Sunday to Tuesday: 6:00PM – 6:30AM
• Week 2
o Sunday to Wednesday: 6:00PM – 5:30AM
OR
Shift B-Rotation
• Week 1
o Wednesday to Saturday: 6:00PM – 5:30AM
• Week 2
o Thursday to Saturday: 6:00PM – 6:30AM
Essential Functions and Responsibilities
• Develop a comprehensive understanding of and execute GMP proficiently.
• cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
• Supports technical transfer and additional research-level testing activities as needed.
• Perform basic revisions as needed to reflect current procedures accurately.
• Support departmental projects in a contributor capacity.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required.
• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Travel - 5% travel, based on business needs.
Required Education, Skills, and Knowledge
• Bachelor's degree or some post-secondary education
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new techniques.
• Must be able to deal with ambiguity – ready to change gears and plans quickly and manage constant change.
• Must read, write and understand English, especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly
• Ability to work successfully in a fast-paced, team-oriented
Preferred Education, Skills, and Knowledge
• Minimum 1+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
• Proactive, results-oriented, self-starter with experience in a complex manufacturing
The Aseptic Manufacturing Technician II role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Manufacturing Technician will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work on weekends and holidays.
Shifts: A or B
Shift A-Rotation
• Week 1
o Sunday to Tuesday: 6:00PM – 6:30AM
• Week 2
o Sunday to Wednesday: 6:00PM – 5:30AM
OR
Shift B-Rotation
• Week 1
o Wednesday to Saturday: 6:00PM – 5:30AM
• Week 2
o Thursday to Saturday: 6:00PM – 6:30AM
Essential Functions and Responsibilities
• Develop a comprehensive understanding of and execute GMP proficiently.
• cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, which include a review of SOPs, Batch Records, Deviations, CAPAs, etc.
• Supports technical transfer and additional research-level testing activities as needed.
• Perform basic revisions as needed to reflect current procedures accurately.
• Support departmental projects in a contributor capacity.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required.
• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Travel - 5% travel, based on business needs.
Required Education, Skills, and Knowledge
• Bachelor's degree or some post-secondary education
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new techniques.
• Must be able to deal with ambiguity – ready to change gears and plans quickly and manage constant change.
• Must read, write and understand English, especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly
• Ability to work successfully in a fast-paced, team-oriented
Preferred Education, Skills, and Knowledge
• Minimum 1+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA
• Proactive, results-oriented, self-starter with experience in a complex manufacturing
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