Drug Product Manufacturing Associate I - 2nd Shift

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); Sur place; USD 30 000 - 36 000; Plein temps

Avantages offerts par ce poste

Health insurance

Flexible spending account

401(k) plan

Paid time off

Résumé du poste

PCI Pharma Services is hiring a Manufacturing Associate I to execute GMP production of injectable pharmaceuticals in a compliant FDA-regulated facility. The role involves preparing equipment and materials for aseptic operations and operating glasswashers, autoclaves, depyrogenation ovens, and filling machines.

The position is 2nd shift, typically 2:00PM–10:30PM with a 10% pay differential and potential annual bonus.

Qualifications

• Bachelor's degree in science or engineering preferred.
• Zero to two years of relevant experience in manufacturing or engineering.
• Detail oriented with strong written and verbal communication.
• Familiarity with cGMP, manufacturing processes, and data entry.
• Proficient with Microsoft Office applications.

Responsabilités

• Train in aseptic manufacturing of injectable pharmaceuticals using GMP in a FDA regulated facility.
• Train on required SOPs and execute the training curriculum.
• Prepare materials needed for aseptic operations and operate equipment.
• Document batch records accurately and consistently.
• Maintain clean room environment and adhere to safety policies.

Connaissances

Detail oriented

Written and verbal communication

GMP knowledge

Formation

Bachelor's degree in science or engineering

Outils

Microsoft Office

Description du poste

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.

Manufacturing Associate I

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.

2nd Shift Hours: Generally M-F: 2:00PM - 10:30PM* Need for flexibility based on Manufacturing schedule. *Eligible for 10% pay differential when working 2nd shift hours.

Essential Duties and Responsibilities:

• 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].
• 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.

Qualifications:

• 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.

Compensation:

*The hiring rate for this position is $21.98 -$25.64 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.

Benefits:

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.

#LI-KC1 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.

Company Culture:

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.