Downstream Manufacturing Associate III (2nd Shift)
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Downstream Manufacturing Associate III (2nd Shift) page is loaded Downstream Manufacturing Associate III (2nd Shift) Apply locations Milford, MA, United States time type Full time posted on Posted 2 Days Ago job requisition id JR1560 Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals.
From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.
In Stevenage, UK, we have launched Rentschler ATMP Ltd.
dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.
400 employees from 25 nationalities.
What unites us at Rentschler Biopharma, is the passion for what we do.
We empower our clients to help patients with serious or rare diseases.
With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals.
Thus, we provide an important contribution to the global availability of essential therapies.
Going forward, we are expanding our team to ensure our long-term sustainable growth.
Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together! Key Experience for Manufacturing Associate, Downstream Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs Specific equipment/systems that we are using include, Akta ready, Akta Process, XDUos buffer systems and disposable technology systems Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing Characteristics:
adaptable to changes, works well cross functionally and with key stakeholders; self-motivated, takes initiative and drives for solutions with the team; can lead in the absence of the manager; could train newer operators once up to speed Other possible responsibilities may include writing deviations/investigations and revising batch records if needed Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities):
Strong knowledge and understanding of manufacturing process and equipment to perform various production steps.
Ability to train employees.
Subject matter expert operating production equipment, as needed.
Monitor and record batch parameters, including computer data entry.
Complete relevant paperwork following GDP/GMP guidelines.
Perform mathematical calculations related to production processes.
Initiate new documents for procedures; may make minor revisions to existing documents.
Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
Troubleshoot process problems and respond to alarms.
Provide information for unplanned events, including entering data into event management software.
Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.
Order, receive and distribute supplies into production area as needed.
Pushing buffer containers ranging from 50L to 200L.
Sitting for periods of 2 to 3 hours.
Knowledge of laboratory and pharmaceutical production equipment including but not limited to:
autoclaves, process tanks, chromatography skids and columns, analytical equipment.
Convey information to external stake holders (auditors, global colleagues, etc.
) Oversee support for groups that support manufacturing (such as external cleaners, etc.
) Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.
) Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers Provide knowledge in areas of training process improvements Such additional responsibilities as the Company may also assign Qualifications With high school diploma:
Normally requires 6
years of related experience required or an associate degree in Life Sciences/Engineering field; Biotech Certificate preferred With Bachelor's degree:
Normally requires 4
years of related experience Demonstrated knowledge of CGMP manufacturing Knowledge of laboratory and pharmaceutical production equipment.
Able to read and follow detailed written instructions and have good verbal/written communication skills Able to write legibly and grammatically correct entries on records.
Must be able to author technical procedures and create forms Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.
) Good computer skills, knowledge of Microsoft Word, Excel Good interpersonal skills and be able to work effectively and efficiently in a team environment Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule Ability to work in a clean room environment and comply with hygiene standards and use of special garments.
Additionally, personal protective equipment must be worn due to safety requirements Working Conditions Normal office working conditions:
computer, phone, files, fax, copier Personal Protective Equipment must be worn as required May require lifting amounts of 25 lbs Manufacturing operations tasks requires operator to regularly remain on feet for shift Physical Requirements PPE as required May require lifting amounts of 25 lbs Manufacturing operations tasks requires operator to regularly remain on feet for shift.
Similar Jobs (2) Downstream Manufacturing Associate II (2nd Shift) locations Milford, MA, United States time type Full time posted on Posted 2 Days Ago Downstream Manufacturing Associate III (1st Shift) locations Milford, MA, United States time type Full time posted on Posted 9 Days Ago #J-18808-Ljbffr Recommended Skills Biotechnology Business Process Improvement Calculations Certified Global Meeting Planner Clinical Works Communication Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
I agree and may revoke or change my consent at any time with effect for the future.
Downstream Manufacturing Associate III (2nd Shift) page is loaded Downstream Manufacturing Associate III (2nd Shift) Apply locations Milford, MA, United States time type Full time posted on Posted 2 Days Ago job requisition id JR1560 Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals.
From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.
In Stevenage, UK, we have launched Rentschler ATMP Ltd.
dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.
400 employees from 25 nationalities.
What unites us at Rentschler Biopharma, is the passion for what we do.
We empower our clients to help patients with serious or rare diseases.
With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals.
Thus, we provide an important contribution to the global availability of essential therapies.
Going forward, we are expanding our team to ensure our long-term sustainable growth.
Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together! Key Experience for Manufacturing Associate, Downstream Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs Specific equipment/systems that we are using include, Akta ready, Akta Process, XDUos buffer systems and disposable technology systems Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing Characteristics:
adaptable to changes, works well cross functionally and with key stakeholders; self-motivated, takes initiative and drives for solutions with the team; can lead in the absence of the manager; could train newer operators once up to speed Other possible responsibilities may include writing deviations/investigations and revising batch records if needed Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities):
Strong knowledge and understanding of manufacturing process and equipment to perform various production steps.
Ability to train employees.
Subject matter expert operating production equipment, as needed.
Monitor and record batch parameters, including computer data entry.
Complete relevant paperwork following GDP/GMP guidelines.
Perform mathematical calculations related to production processes.
Initiate new documents for procedures; may make minor revisions to existing documents.
Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.
Troubleshoot process problems and respond to alarms.
Provide information for unplanned events, including entering data into event management software.
Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.
Order, receive and distribute supplies into production area as needed.
Pushing buffer containers ranging from 50L to 200L.
Sitting for periods of 2 to 3 hours.
Knowledge of laboratory and pharmaceutical production equipment including but not limited to:
autoclaves, process tanks, chromatography skids and columns, analytical equipment.
Convey information to external stake holders (auditors, global colleagues, etc.
) Oversee support for groups that support manufacturing (such as external cleaners, etc.
) Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.
) Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers Provide knowledge in areas of training process improvements Such additional responsibilities as the Company may also assign Qualifications With high school diploma:
Normally requires 6
years of related experience required or an associate degree in Life Sciences/Engineering field; Biotech Certificate preferred With Bachelor's degree:
Normally requires 4
years of related experience Demonstrated knowledge of CGMP manufacturing Knowledge of laboratory and pharmaceutical production equipment.
Able to read and follow detailed written instructions and have good verbal/written communication skills Able to write legibly and grammatically correct entries on records.
Must be able to author technical procedures and create forms Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.
) Good computer skills, knowledge of Microsoft Word, Excel Good interpersonal skills and be able to work effectively and efficiently in a team environment Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule Ability to work in a clean room environment and comply with hygiene standards and use of special garments.
Additionally, personal protective equipment must be worn due to safety requirements Working Conditions Normal office working conditions:
computer, phone, files, fax, copier Personal Protective Equipment must be worn as required May require lifting amounts of 25 lbs Manufacturing operations tasks requires operator to regularly remain on feet for shift Physical Requirements PPE as required May require lifting amounts of 25 lbs Manufacturing operations tasks requires operator to regularly remain on feet for shift.
Similar Jobs (2) Downstream Manufacturing Associate II (2nd Shift) locations Milford, MA, United States time type Full time posted on Posted 2 Days Ago Downstream Manufacturing Associate III (1st Shift) locations Milford, MA, United States time type Full time posted on Posted 9 Days Ago #J-18808-Ljbffr Recommended Skills Biotechnology Business Process Improvement Calculations Certified Global Meeting Planner Clinical Works Communication Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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