Engineer II - MTS/MSAT

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Summary of Objective:

The Manufacturing Science and Technology (MTS) Engineer II is responsible for supporting the execution of manufacturing processes in a CMO multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug products and medical devices. Additional roles include using operational and technical knowledge to lead troubleshooting activities, support new product implementation (tech transfer), lead start-up activities (process design, batch record development), provide compliance and regulatory/inspection support, analyze process data, and identify and implement process and manufacturing improvements. Ensure timely and complete investigations of unplanned process related deviations and trends with the guidance.

Essential Duties and Responsibilities:

• Work with process development teams (external clients, internal project managers and R&D) to transition products through the technology transfer timeline

• Implementation and ongoing support of FDA compliant manufacturing of Medical devices and drug products

• Work with clients to deliver on all clinical and commercial raw materials supply requirements through process ownership, trouble shooting and transfer of robust manufacturing processes

• Support the processing and composition of FMEA risk assessments with cross-functional departments and integration of robust and reliable manufacturing scale equipment into production

• Support technology transfer into GMP manufacturing by generating process description/ technology transfer documents/reports, developing and reviewing master batch records and appropriate documentation for GMP operation (batch records, standard operating and material control procedures) and providing on-floor support for these GMP manufacturing operations

• Evaluation of unit operations used in manufacturing. Support change control processes if appropriate to implement new process operations

• Troubleshooting of process disturbances, identifying resolution and implementing corrective and preventive measures, as required. Proactive and real-time support of critical operations.

• Perform process monitoring and data analysis including real time review of process parameters and process data/trend analysis. Communicate process performance across departments

• Serve as the operations subject matter expert (SME) for technology transfer and start-up of products by reviewing process parameters, site assessments, develop manufacturing batch records, applicable process change controls, sampling plans, and other tech transfer deliverables

• Actively support process and product related investigations, execute CAPAs and provide input to process and equipment change controls to ensure robust and capable solutions

• Anticipate potential issues before they arise by relying on prior experience and gaining new industry knowledge

• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA, EU, QSR and ISO regulations 

• Support to ensure that all technical issues are resolved in order to meet production demand and product release

• Participate in the investigation of failures and implement action plans for all internal corrective actions, audit findings.

• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to client’s products

• Provide manufacturing operations with “on-floor” manufacturing technical support

• Utilize concepts of root cause analysis for generation of complete and concise investigation reports resolving quality discrepancies and deviations during GMP production

• Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues.

• Proficiency with Microsoft products and ability to learn additional applications as needed

• Must be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors

• Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products

• Understanding of new manufacturing technologies including single use disposables

• Process Engineering/development experience in the biotechnology/pharmaceutical/medical device industry with practical expertise around scale-up, tech transfer and manufacturing support to large scale GMP operations is required  

• Familiarity with the operation of large-scale disposable technologies, devices and production equipment for unit operations is highly preferred  

• Proven track record of large-scale process implementation  

• General understanding of fill finish, freeze drying (lyophilization), medical device, filtration, milling, mixing technologies, fluid metering, formulation, and purification  

• Knowledge of equipment in pharmaceutical manufacturing including autoclave, filling pump, vial washer, depyrogenation oven, lyophilizers, and process utilities (WFI, PW, Clean Steam, HVAC, etc.).

Qualifications:

• BS degree in an Engineering discipline with preference for Chemical of Life Sciences with 4+ years industry experience within a pharmaceutical, biotechnology/medical device or FDA/ISO regulated industry.  Comparable blends of education and experience is acceptable.    
• Resilient, can quickly move forward despite challenges 
• A drive to achieve results while working with limited supervision 
• Positive attitude and strong team, cross team collaboration  
• Honesty, integrity, respect and courtesy with leadership and peers   
• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services 

 
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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.