Drug Product Manufacturing Associate II - 2nd Shift

PCI Pharma Services; San Diego (CA); On-site; USD 37,195 - 44,083; Full time

Job summary

PCI Pharma Services in San Diego, CA is seeking a Manufacturing Associate II to execute GMP production of injectable pharmaceuticals by following SOPs and preparing equipment for aseptic processing. You will operate equipment such as glasswashers, autoclaves, de-pyrogenation ovens, and automated filling machines on the 2nd shift starting at 2:00 pm.

The role requires a high school diploma, at least two years in manufacturing or related fields, and familiarity with cGMP.

Qualifications

• High school diploma required; bachelor’s degree in science/engineering preferred.
• Minimum two years of relevant manufacturing or lab experience.
• Ability to work in a GMP/cGMP environment with proper documentation.

Responsibilities

• Perform aseptic GMP manufacturing activities for injectable products.
• Assist in troubleshooting equipment with technical staff.
• Prepare components, media, buffers, and other solutions.
• Accurately document batch records under cGMP guidelines.
• Operate equipment such as glasswashers, autoclaves, and filling machines.
• Maintain regular attendance and collaborate with cross-functional teams.

Skills

Cross-functional teamwork

Detail oriented

Written communication

Verbal communication

Independent work

GMP knowledge

Education

High school diploma

Bachelor's degree in science or engineering preferred

Tools

Microsoft Office

Job description

The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOPs. Manufacturing associates prepare equipment and materials for GMP aseptic production and operate equipment such as glasswashers, autoclaves, de‑pyrogenation ovens, and automated filling machines.

Essential Duties and Responsibilities

• Participate in one or more areas of aseptic manufacturing of injectable pharmaceuticals using GMP in a FDA‑regulated facility.
• Assist technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment.
• Perform various semi‑routine manufacturing tasks under established SOPs and cGMP regulations.
• Troubleshoot manufacturing processes that are semi‑complex within cGMP guidelines and under management supervision.
• Assist in research and implementation of new methods and technologies to enhance operations.
• Prepare components, media, buffers, and other solutions as needed.
• Accurately document data and write/review batch records under cGMP guidelines.
• Prepare material components for production.
• Maintain regular and reliable attendance on a full‑time basis (or as posted).
• Exhibit professional behavior with internal and external business associates that reflects positively on the company and aligns with company policies.
• Embodies PCI Pharma Service’s cultural values and aligns daily actions with departmental goals and company culture.

Schedule

2nd Shift: Starts at 2:00 pm

Qualifications

• High school diploma required; bachelor’s degree 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 or as a team member within prescribed guidelines.
• 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

• Constantly perform duties while donning aseptic gowning.
• Constantly required to sit and reach to use computers and other office equipment.
• Constantly stand for extended periods of time, up to four (4) hours at a 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: In this summary, occasionally represents up to 1/3 of the time, frequently represents 1/3 to 2/3 of the time, and constantly represents 2/3 or more of the time.

Compensation: $27.09–$31.60 per hour plus eligibility for an annual performance bonus. PCI offers a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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.