Description:

Job Description

Aseptic Manufacturing Operations Technician of Commercial Drug Products

• Perform Formulations /Calculations for Drug Batch( liquid, powder, or solid)

• Compounding / Filtration / Syringe and Vial Fills/ Media Preparations

• Autoclave / Sterile Instrument/ Glass/ and Vial Wash Machine Operation

Job Overview:

The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. The Manufacturing Technician will be responsible for the filtration and filling of a range of pharmaceutical products for clinical and commercial use.

Responsibilities:

•\tComplete and maintain aseptic qualification training.

•\tObtain basic understanding of a task, unit operation and/or document (forms and/or SOPs) while aiding with oversight from Manufacturing Technician III and above.

•\tAttain and maintain gowning qualification per appropriate SOPs.

•\tFollow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.

•\tPrepare and maintain accurate documentation following cGMP and GDP principles.

•\tEnsure documentations are completed in real-time in accordance to CGMP and GDP principles.

•\tAdhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.

•\tSupport QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.

•\tWork collaboratively with internal teams to meet site goals and objectives as part of a team.

•\tInitiate and foster a spirit of cooperation within and between departments.

•\tReview documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).

•\tMaintain all personal cGMP related training in a current state.

•\tAchieve and maintain cleaning and sanitization of cleanroom training.

•\tParticipate in Aseptic media qualification per the appropriate qualification protocol.

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

•\tParticipate in personnel monitoring as requested.

•\tWork closely with Operational Excellence to identify and implement process improvements.

•\tSet up and breakdown the filling equipment per appropriate SOPs.

•\tInteract with filling machines at the validated speeds and volumes.

•\tPerform volume checks.

•\tPerform and document inherent and non-inherent interventions.

•\tEnsure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.

•\tWork with R&D and tech transfer team for successful transfer of Programs

•\tPerform all aseptic connections, respecting first air.

•\tPerform pre- and post-filter integrity testing as required.

•\tAseptically sterile filter products into appropriate vessels.

•\tComplete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.

•\tAttain and maintain ability to perform environmental tasks as required.

•\tPerform other duties as assigned.

Additional Skills & Qualifications:

Qualifications:

•\tHigh school diploma or equivalent with 1-3 years’ experience, Bachelor’s degree with a minimum of 1 year of experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

•\tPrior experience in related field, preferred.

•\tcGMP manufacturing knowledge, preferred.

•\tAseptic filling and general production knowledge, preferred.

•\tDemonstrate basic math skills.

•\tDemonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

•\tDemonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

•\tDemonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

•\tMust be able to comprehend and follow all applicable SOPs.

•\tDemonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

•\tDemonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

•\tGood understanding of cGMPs, industry, and regulatory standards and guidelines.

•\tDemonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

•\tDemonstrate the ability to portray the appropriate level of integrity and professionalism.

•\tDemonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

•\tDemonstrate the ability to complete tasks accurately and according to established and shifting timelines.

•\tDemonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

•\tEnergetic, execution-focused, self-motivated, and organized individual who is accustomed

WHY ACTALENT

Work with a dedicated career partner specialized in your healthcare skill setWe advocate on your behalf so you get what you want and need out of your jobGet performance feedback, career advice, and access to ongoing professionaldevelopment toolsBuild your career and learn new skills through projects as diverse as your curiosityYou are eligible for benefits, paid-time-off, and competitive wages that are paid weekly

ABOUT ACTALENT

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.