Specialist I ,MSAT

Specialist I ,MSAT

Department: Validation

Location: Monroe, NC

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POSITION SUMMARY

The Specialist I, MSAT will provide technical support to optimize commercial manufacturing processes and commercialize new products and technologies. This role is responsible for supporting project activities for new product introductions into the Monroe site. This will include activities such as scale-up batches, equipment/systems qualifications, exhibit/registration batches, and process/cleaning validations. In addition, this role is involved in continuous improvements through data analysis, regulations updates and industry standards applicable to aseptic/ sterile drug products.

JOB RESPONSIBILITIES

Knowledge & Skills(Functional/Technical)

• Ability to detect gaps in the manufacturing process, potential for process improvements /optimization, and ability to work in teams to ensure resolution of technical issues in manufacturing and guarantee adequate process capability and process control for all products.

• Ability to understand pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting,

• Ability to understand equipment & facility qualifications, computer system validations, and cleaning validation.

• Ability to learn Manufacturing Operation of Sterile /Parenteral formulations and related equipment (as applicable for the sites). (Vial washer, tunnel, filling, capper, Lyophilizer, PFS, Manufacturing and filtration vessel, labelling, Inspection. Utilities: Water for Injection Generation and distribution, Purified water Generation, Compressed air, Pure steam & Nitrogen)

• Good technical report writing and review skills

• Develop protocols for scale-up and optimization, exhibit, pre-validation, process performance qualification, hold time studies, and investigational studies based on a risk-based approach.

• Support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishment of the root cause using a data-driven and science-based approach.

• Support to internal and external audit observations concerning manufacturing, process & validation-related deficiencies.

• Attend technical training concerning CQAs, CMAs, and CPPs, improvement in mfg. Process and process controls.

• Perform statistical evaluations (Running Chart, Box plot, Regression analysis, Cpk, and Ppk) of data and science-based and logical interpretation of data. Ability to use Minitab/JMP software.

• Technical coordination with R&D/PDL/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.

• Coordination with cross-functional teams and assistance in resolving problems encountered during batch production and investigation (as required), assessing timelines, and ensuring resolution per the timelines.

Operational Excellence

• Validation Protocol and Report preparation

• Prepare validation Protocol and Report as per guidelines and regulatory requirements.

• Qualification of Manufacturing Equipment/ Systems/ Instruments.

• Ability to learn new processes and equipment independently.

• Good problem-solving and critical-thinking skills.

• High mechanical aptitude and ability to learn and understand new technical information.

• Ability to gown and work on the production floor in an aseptic manufacturing environment

• Proficiency with Microsoft Word, Microsoft Excel, and PowerPoint is required.

KNOWLEDGE, SKILLS AND ABILITIES

Education

(degree)

Minimum-B.S. Pharmaceutical Sciences / B.S. Engineering preferred MS Pharmaceutical Sciences / MS Engineering.

Experience

Specialist I 0-3 years in the Pharmaceutical Industry (FR&D/PDL/Tech. Services/MS&T).

Knowledge and Skills (Functional / Technical)

Functional:

• Ability to learn product development, pre-formulation studies, and lab-scale batches.

• Ability to learn pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting,

• Ability to learn process performance qualifications, continued process verification (CPV), and continuous process improvement.

• Ability to learn equipment, facility qualifications, and computer system validations (CSV).

• Understanding of data analytics and data interpretation

• Ability to learn Technical Investigation and Root Cause Analysis Techniques

• Good technical report writing and review skills

• Ability to learn regulatory intelligence and guidelines in the pharmaceutical industry.

Other skills:

• Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility

Leadership / Managerial Attributes

Problem-solving & technical decision-making, relationship building, innovation and creativity, teamwork & collaboration, result orientation, time management, agility, and adaptability. Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility

Other requirements (licenses, certifications, specialized training)

Understanding of material science (AVD), Specialized training in Statistics, and Six Sigma certifications. etc.,

Ability to learn Aseptic Manufacturing.

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