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Entry Level Manufacturing Associate

Company: Actalent
Location: Dublin
Posted on: January 15, 2022

Job Description:


Manufacturing Associate

o Swing Monday 3:00 to 11:30 pm (10% Shift Differential)

Asking pay rate range based on experience from $24 to $27

Job Summary

Provide technical assistance to the Humira Bulk Drug Substance (BDS) Manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave) related to the manufacturing process and equipment. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant.

This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the BDS manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover.

Develop and modify procedures as needed to support the manufacturing operation.

Participate in process, equipment, and facilities validations efforts and projects implementations.

Investigate process exceptions or equipment malfunction incidents affecting the process.

Maintain the Manufacturing area equipment in compliance with the calibration and maintenance programs. Participate in the internal EHS and Quality audits.

Major Responsibilities

+ Comply with our client's Corporate and Divisional policies and procedures, ABL Plant procedures, and regulatory agencies regulations and requirements.

+ Provide technical assistance to the manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave).

+ Assist in the troubleshooting of the manufacturing equipment and process.

+ Investigate process and equipment exceptions and follow up CAPA implementation.

+ Revise SOPs and PCR and submit Change Requests (CR) for approval.

+ Develop and implement changes that will improve equipment performance and consequently product quality in the Bulk Drug Substance Manufacturing Areas (Upstream, Downstream and Central Services Areas) and reduce manufacturing costs.

+ Evaluate and implement new equipment technology.

+ Establish requirements and assist in the implementation of changes to the Process Control System.

+ Participate in the development and execution of validation protocols. Participate in the manufacturing personnel training.

+ Give direct support to the manufacturing process and trouble shootings.

+ Provide assistance to the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits.

Position Accountability

Demonstrated ability to contribute in a multi-disciplinary team environment.

* Should have a high degree of initiative and responsibility which would enable incumbent to perform efficiently with a minimum of supervision.

* Project Management Skills - Ability to take programs from concept to execution and manage all stages. Provide leadership to assigned teams by communicating and providing guidance towards achieving group objectives.

* Provide technical assistance to maintain manufacturing equipment and process continuity avoiding losses due to poor production equipment performance.

* Incumbent must work with other groups (ex. Maintenance, Engineering, Quality, Validations, Technical Operations/Tech Center, Computer Systems) influencing them to achieve their objectives to implement equipment and process improvements and at the same time, maintain a constant product turnover.

Educational Requirements

Bachelor Degree in Sciences (i.e.. Biology, Chemistry, Engineering).

* Proven ability to effectively meet manufacturing goals by established dates in team setting.

* Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, and EN46000), knowledge of corporate, local, state, and OSHA regulation.

* Excellent verbal and written communication skills in both, English and Spanish.

Experience Requirements

* At least five (5) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.

* Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations preferable.

* Knowledge in manufacturing equipment's troubleshooting.

* Previous experience with Control Systems; Delta V and MES preferable.

Mental & Physical Abilities

1. Incumbent will deal with difficult technical problems in a highly technical and regulated biologics plant.

2. Must have the ability to focus, take initiative, cope with stress, and use judgment to accomplish results.

3. Excellent interpersonal skills that will permit effective interaction with peers, contractors, and customers.

4. Proven ability to effectively meet project goals by established dates in team setting.

5. Provide a team environment as to maintain highly motivated work force.

6. Must be able to communicate in English, both oral and written.

7. Excellent skills for managing teamwork with other departments of interaction.

8. Skills to operate computer automated systems.

9. Skills to understand technical information, in English.

10. Computer knowledge (Power Point, Excel, and Microsoft Word).

11. Ability to work with multiple priorities in a work environment with frequent interruptions.

Lifting requirement: 25 lbs (rare)

* Assembly experience

* Basic GMP/GDP

* Tech savvy

* Good with email

* Some Excel


manufacturing process, gmp, excel data entry, assembly

Additional Skills & Qualifications:

* Assembly experience

* Basic GMP/GDP

* Tech savvy

* Good with email

* Some Excel

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

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

Keywords: Actalent, Dublin , Entry Level Manufacturing Associate, Other , Dublin, California

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