Validation Technician

Company:

Adare Pharma Solutions

Location:

Philadelphia, PA

Posted:

April 14, 2024

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Description:

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?

Medical/dental/vision/life – low employee premiums

401k with a highly competitive match

Generous PTO, including floating holidays

Career growth and internal opportunities

Tuition reimbursement

Relocation assistance

Performance-based bonus

Employee Recognition Programs

We are seeking to hire a Technician to join our team.

If any of the below describes you, we would love to meet you!

JOB SUMMARY

The Technician is a valuable member of the Technical Services and Validation team, and provides support to the R&D group in performing Product development, Process development and improvement, Scale up, and Validation activities as mandated by cGMP’s policies/procedures and quality standards.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

Assist Process Engineers and/or Validation Scientists in running projects associated with alternate sources of raw materials, technical transfers, scale up/down, process development, product and process optimization batches, and on completion to ensure robustness of the process and formulation.

Assist Process Engineers and/or Validation Scientists in coordinating cleaning, process validation and technical / process operations activities with company quality units, operation, R&D and regulatory affairs for commercial or R&D products.

Assist Process Engineers and/or Validation Scientists in executing cleaning, process validation and/or technical / process operations protocols, ensure sampling and testing are completed as planned, collate all in-process and analytical data, assist in writing reports and preparing master formulary records.

Follow protocol and batch records in manufacturing development batches and relate observations to Process Development Scientists and/or R&D Product Development group.

Follow departmental and company SOPs and policies.

Must participate and successfully complete all training as required by the company.

Perform other duties as assigned.

Requirements

Associate Degree with 1+ year(s) experience in a pharmaceutical environment or equivalent combination of education and experience.

Cross trained in the manufacturing unit operations such as granulation, blending, compression, coating and encapsulation; or equivalent combination of education and experience highly desired.

Knowledge of manufacturing equipment such as granulators, tableting machines, coaters, and encapsulator is essential.

Mechanical skills/ability required.

Excellent oral and written communication skills required.

cGMP knowledge is essential.

Knowledge of analytical laboratory testing and regulatory filing requirements is a plus.

Proficient in the use of Microsoft Office and other applications as applicable, plus the ability to learn company used applications as required.

Ability to travel occasionally as required and ability to work occasional shift and weekend work as required.

Ability to read and interpret documents

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.

Ability to deal with problems involving a few concrete variables in standardized situations.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands to handle or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand; walk; sit and taste or smell. The employee is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move more than 100 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in a manufacturing and/or laboratory environment.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.

Benefits