Drug Product Manufacturing Associate I - 1st Shift

Manufacturing Associate I

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

Our investment is in people who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manufacturing Associate I is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

Essential duties and responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.
• Train on required SOP's and execute training curriculum.
• Prepare materials needed for aseptic operations.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Performs various routine manufacturing tasks on complex equipment under the guidelines of established SOP's and cGMP regulations.
• Accurately documents data and completes batch records as needed.
• Reliably executes well defined SOP's.
• Operates in clean room environments in accordance with established policies and procedures.
• Collects and disposes of lab wastes according to established procedures.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• High school diploma required. Bachelors in a science or engineering discipline preferred.
• Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• Ability to follow instructions with direct supervision.
• Detail oriented with strong written and verbal communication skills.
• Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
• Familiarity with cGMP, manufacturing, machine operations, and data entry.
• Must be familiar with Microsoft Office applications.

Physical Demands: While performing the duties the employee is:

• occasionally required to sit, and to reach to use computers and other office equipment
• occasionally stand for extended periods of time, up to four (4) hours/time
• occasionally required to lift up to 40 pounds
• constantly required to view objects at close and distant ranges
• frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.