Summary:

Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Executes process documentation in a fast-paced manufacturing environment. Shift: 2nd, with 1st shift availability expected for initial training and as needed.

Essential Functions:

Maintains cleanliness of work areas and facility with assistance of assigned personnel. Prepares manufacturing suites and components for Production Batch Record execution. Can sign as a verifier on logbooks and other forms. Executes Production Batch Records (PBRs). Executes Work Orders (WOs). Ability to work independently and have experience to be a verifier on at least one line of unit operations. Keeps proper Personal Protective Equipment (PPE) and gowning materials supplied in gowning suite. Maintains cGMP materials inventory according to applicable Standard Operating Procedures (SOP’s). Revises SOPs and generates new SOPs when required. Performs equipment qualification. Cleans and visually inspects the processing equipment, tools, and utensils for cleanliness per the appropriate SOP and documents those activities. Ensures that all cGMP equipment and parts are properly labeled. Performs other technician responsibilities as necessary.

Education:

Associate’s degree and/or military experience preferred; HS Diploma required.

Experience:

Minimum of one (1) year of production experience in the pharmaceutical industry preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications preferred. Pharma or biotech experience highly preferred. Proven track record of producing an excellent work product with a high degree of accuracy. Ability to multi-task and handle shifting priorities in a fast-paced manufacturing environment. Strong proficiency in Microsoft Office Suite (Word and Excel). Effective written and interpersonal skills.

Physical Requirements:

Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing suite setting. 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 duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply 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, administered by our third-party vendor, as a condition of employment.