Drug Product Manufacturing Associate I - 1st Shift

PCI Pharma Services; San Diego (CA); On-site; USD 46,000 - 53,000; Full time

Benefits offered by this job

Health insurance (including dental and

Vision coverage

401(k) plan

Paid time off

Job summary

PCI Pharma Services in San Diego, CA is seeking a Manufacturing Associate I to join our team and perform GMP production of injectable pharmaceuticals. This role involves aseptic operations, training across multiple areas, and maintaining strict SOP adherence.

You will prepare materials, document batch records, operate GMP equipment, and work in clean room environments while upholding PCI’s safety, quality, and EHS standards. Competitive pay and benefits offered.

Qualifications

• High school diploma required; bachelor’s degree in a science or engineering discipline preferred.
• Minimum of zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• Ability to follow instructions under 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 processes, machine operation, and data entry.
• Must be familiar with Microsoft Office applications.
• The hiring rate for this position is $21.98 - $25.65 plus eligibility for an annual performance bonus.

Responsibilities

• Train in one or more areas of aseptic manufacturing of injectable pharmaceuticals using GMPs in an FDA regulated facility.
• Complete required SOP training and execute training curriculum.
• Prepare materials needed for aseptic operations.
• Exhibit professional behavior with both internal and external business associates that reflects positively on the company and aligns with company’s policies and practices.
• Perform various routine manufacturing tasks on complex equipment in accordance with established SOPs and cGMP regulations.
• Accurately document data and complete batch records as required.
• Reliably execute well defined SOPs.
• Operate in clean room environments in accordance with established policies and procedures.
• Collect and dispose of lab waste according to established procedures.
• 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.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures

Skills

Attention to detail

Communication

Instruction adherence

Education

High school diploma

Bachelor’s degree in science or engineering (preferred)

Tools

Microsoft Office

Job description

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

We are PCI.

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 while following all applicable SOPs. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

This is an evergreen posting intended to build our candidate pool for current and future hiring needs.

Essential Duties And Responsibilities

• Train in one or more areas of the aseptic manufacturing of injectable pharmaceuticals using GMPs in an FDA regulated facility.
• Complete required SOP training and execute training curriculum.
• Prepare materials needed for aseptic operations.
• Exhibit professional behavior with both internal and external business associates that reflects positively on the company and aligns with company’s policies and practices.
• Perform various routine manufacturing tasks on complex equipment in accordance with established SOPs and cGMP regulations.
• Accurately document data and complete batch records as required.
• Reliably execute well defined SOPs.
• Operate in clean room environments in accordance with established policies and procedures.
• Collect and dispose of lab waste according to established procedures.
• 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.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures

Special 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

• occasionally 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
• constantly performs duties while donning aseptic gowning.
• Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Qualifications

• High school diploma required; bachelor’s degree in a science or engineering discipline preferred.
• Minimum of zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• Ability to follow instructions under 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 processes, machine operation, and data entry.
• Must be familiar with Microsoft Office applications.
• The hiring rate for this position is $21.98 - $25.65 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees 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.

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.