Sr. Process Engineer

PCI San Diego, Inc.; San Diego (CA); On-site; USD 107,000 - 134,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Flexible spending account

401(k)

Job summary

PCI Pharma Services in San Diego is seeking an experienced manufacturing process engineer to design and optimize pharmaceutical and biopharmaceutical processes, improve efficiency and yield, and mentor junior engineers.

You will lead technical assessments, manage scale-up projects, review documents, and drive continuous improvement while coordinating with cross-functional teams across facilities.

Qualifications

• Bachelor's degree required; 8+ years of relevant experience; 6+ years of cGMP experience; Advanced knowledge of manufacturing processes; Mastery of process flow and troubleshooting; Advanced understanding of GMP regulations and requirements

Responsibilities

• Design and specify processes and manufacturing equipment systems
• Evaluate existing systems for continuous improvement
• Provide in-depth technical review of all documents
• Research new technologies and implement new/upgraded systems
• Document changes to systems per change management procedures
• Travel between facilities to support all manufacturing processes
• Regular and reliable attendance on a full time basis
• Responsible for exhibiting professional behavior with internal and external business associates reflecting company policies
• Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture

Skills

Process design

cGMP experience

GMP knowledge

Process troubleshooting

Travel between facilities

Education

Bachelor's degree in Bioengineering/ChE/EE/IE/ME or equivalent

Job description

SUMMARY:

Design and optimize pharmaceutical and biopharmaceutical manufacturing processes for improved efficiency and yield. Supports manufacturing operations and mentor junior engineers. Lead technical assessment and improvement/scale up projects for manufacturing processes, including managing projects through to successful completion.

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Design and specify processes and manufacturing equipment systems
• Evaluate existing systems for continuous improvement
• Provide in-depth technical review of all documents
• Research new technologies and implement new/upgraded systems
• Document changes to systems per change management procedures
• Travel between facilities to support all manufacturing processes
• 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.

EDUCATION AND EXPERIENCE:

• Bachelor's degree required (Bioengineering, ChE, EE, IE, ME, or similar) or Exceptions for equivalent work experience
• Minimum eight (8) years of relevant experience
• Minimum six (6) years of cGMP experience
• Advanced knowledge of manufacturing processes
• Mastery of process flow and troubleshooting
• Advanced understanding of GMP regulations and requirements

The base salary hiring range for this position is $106,800 - $133,500 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), flexible spending account, and 401(k).

• paid time off
• health insurance coverage (including dental and vision)
• flexible spending account
• 401(k)

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Join us and be part of building the bridge between life changing therapies and patients.

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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.

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.