Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Aseptic Manufacturing Technician II/Sr./Lead (Day shift)
300 Rouse Boulevard Philadelphia, PA 19112 US
Posted: 12/16/2024
2024-12-16
2025-02-15
Employment Type:
Contract To Hire
Job Category: Scientific
Job Number: 616269
Is job remote?: No
Country: United States
Job Description
Fully onsite in PA
Aseptic Manufacturing Technicians to join the Operations team for the new manufacturing site.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.
Specific Responsibilities
• Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
• Complete training sessions and ensure training documentation is maintained.
• Understands and complies with quality standards and requirements as documented.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research level testing activities.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends the daily lab 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 ability to recognize deviation from accepted practice is required.
• Other duties as assigned.
Qualifications
• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• 1-5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to core values, policies, procedures and business ethics.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• May require up to 5% travel, based on business need.
Physical Requirements
• Must be able to work in environment with variable noise levels
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• Ability to stand/sit/walk for long periods of time
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
• Ability to lift 20 lbs
Shifts: Wednesday - Saturday or Sunday - Wednesday (4 Days a week / 10 hours each)
Aseptic Manufacturing Technicians to join the Operations team for the new manufacturing site.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.
Specific Responsibilities
• Develop a comprehensive understanding of and be able to proficiently execute current cell therapy manufacturing process.
• Complete training sessions and ensure training documentation is maintained.
• Understands and complies with quality standards and requirements as documented.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research level testing activities.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends the daily lab 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 ability to recognize deviation from accepted practice is required.
• Other duties as assigned.
Qualifications
• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• 1-5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to core values, policies, procedures and business ethics.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• May require up to 5% travel, based on business need.
Physical Requirements
• Must be able to work in environment with variable noise levels
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• Ability to stand/sit/walk for long periods of time
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
• Ability to lift 20 lbs
Shifts: Wednesday - Saturday or Sunday - Wednesday (4 Days a week / 10 hours each)
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