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Job Description

Summary:

In this role, you will be responsible for performing current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Your tasks will include executing process documentation in a fast-paced and flexible manufacturing environment.

Crucial Functions:

Maintain the required cleanliness of equipment, work areas, and the facility. Prepare manufacturing suites and components for the execution of Production Batch Records. Execute Production Batch Records to produce pharmaceutical products. Verify baseline GMP activities. Operate in a safe manner, wearing appropriate Personal Protective Equipment (PPE), and promptly identify and report any safety hazards. Follow established waste disposal procedures. Evaluate processes for continuous improvement. Perform tasks of growing complexity with a higher degree of independence. Perform all duties in compliance with cGMP guidelines. Follow all relevant Standard Operating Procedures (SOPs), Good Documentation Practices, and Data Integrity procedures. Embody the 4i Values: Integrity, Intensity, Innovation, and Involvement. Fulfill other essential technician responsibilities as required.

Education:

HS Diploma or equivalent required.

Experience:

1+ year of work experience in manufacturing/production environment; pharma preferred.

Equivalency:

Equivalent combination of education, training, and meaningful work experience may be considered.

Proficiencies:

To excel in this role, it is preferred to have a good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets, and software applications. Previous experience in the pharmaceutical or biotech industry is highly desired. You should have a proven record of consistently producing high-quality work with a high degree of accuracy. A strong work ethic, mechanical aptitude, and a genuine desire to learn are important qualities. The ability to multitask and handle shifting priorities in a fast-paced and highly regulated manufacturing environment is crucial. Effective written and verbal communication skills are essential for effective collaboration and coordination. Attention to detail and the ability to follow both written and verbal instructions accurately are key attributes for success in this role.

Physical Requirements:

Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing facility. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to build an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Please take note that we require a negative drug screen, coordinated by our third-party vendor, as a condition of employment.