Drug Product Manufacturing Technician I/II/II M-F 4PM to 12:30 AM

About the role

The Manufacturing Technician I at PCI is responsible for performing a variety of tasks within the manufacturing process, adhering to GMP/ISO standards and safety guidelines. This role involves preparing solutions, aseptic filling, and labeling under sterile and non-sterile conditions, as well as operating various equipment in cleanroom and controlled environments.

Responsibilities

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Demonstrates general knowledge of aseptic techniques.
• Prepares solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions.
• Operates vial cappers, unloads product from lyophilizers, and liquid fill lines.
• Prepares equipment and components for sterilization and Lyophilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.
• Sanitizes production areas and prepares equipment for production.
• Completes and maintains documentation related to assigned work, including logbooks, batch records, etc.
• Identifies, escalates, and documents events that deviate from normal operation; participates in investigations.
• Maintains compliance, cleanliness, and orderliness of operational areas per appropriate SOPs.
• Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations.
• Reviews and revises pertinent SOPs and production batch records as required.
• Works closely with cross-functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
• Adapts to a changing process daily (i.e., Formulations vary depending on client product).
• Works under the scrutiny of clients daily and is flexible with the process and adjusting work hours accordingly.
• Communicates effectively, pays attention to detail, demonstrates mechanical aptitude, commits to ethical standards, and embraces continuous improvement.

Qualifications

• 0 – 2 years of working experience, preferably in a manufacturing environment, ideally in the pharmaceutical or medical device industry.
• High school diploma or equivalent.
• Ability to weigh and measure raw materials and operate basic Benchtop instruments.
• Able to follow written instructions and seek help with more complex and non-routine tasks.
• Adapts to a changing process daily (i.e., Formulations vary depending on client product).
• Works under the scrutiny of clients daily and is flexible with the process and adjusting work hours accordingly.
• Good verbal and written skills.
• Pays attention to detail.
• Demonstrates a good mechanical aptitude.
• Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursuing excellence in the manufacturing and delivery of PCI products and services.
• Honors honesty, integrity, respect, and courtesy with leadership and peers.
• Openly receives and implements feedback, resilient, able to move past mistakes; applies learning.
• Self-starter, able to work in a fast dynamic work setting.

Skills

• Knowledge of aseptic techniques.
• Experience with sterile and non-sterile conditions.
• Proficiency in operating various manufacturing equipment.
• Ability to follow written and verbal instructions.
• Attention to detail and mechanical aptitude.
• Commitment to ethical standards and continuous improvement.

Benefits

Join us and be part of building the bridge between life-changing therapies and patients. Let’s talk future.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Variable schedule to accommodate client and product needs.

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.