Drug Product Manufacturing Associate II - 2nd Shift

Drug Product Manufacturing Associate II

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.

Position Title: Drug Product Manufacturing Associate II

Location: Roselle or Lusk

The Manufacturing Associate II 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.

• Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.
• Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment.
• Performs various semi-routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations.
• Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management.
• Assists in the research and implementation of new methods and technologies to enhance operations.
• Prepares components, media, buffers, and other solutions as needed.
• Accurately documents data and writes/reviews batch records under cGMP guidelines.
• Prepares material components for production.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• 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.

• Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture.

Schedule:

2nd Shift: Starts at 2:00pm

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 two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• Ability to work with cross functional teams.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• 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:

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly perform duties while donning aseptic gowning.
• constantly required to sit, and to reach to use computers and other office equipment
• constantly stand for extended periods of time, up to four (4) hours/time.
• frequently required to lift up to 50 pounds
• constantly required to view objects at close and distant ranges with hand and eye coordination
• 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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.