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 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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Work with process development teams (external clients, internal project managers and R&D) to transition products through the technology transfer timelineImplementation and ongoing support of FDA compliant manufacturing of Medical devices and drug productsWork with clients to deliver on all clinical and commercial raw materials supply requirements through process ownership, trouble shooting and transfer of robust manufacturing processesSupport the processing and composition of FMEA risk assessments with cross-functional departments and integration of robust and reliable manufacturing scale equipment into productionSupport 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 operationsEvaluation of unit operations used in manufacturing. Support change control processes if appropriate to implement new process operationsTroubleshooting 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 departmentsServe 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 deliverablesActively support process and product related investigations, execute CAPAs and provide input to process and equipment change controls to ensure robust and capable solutionsAnticipate potential issues before they arise by relying on prior experience and gaining new industry knowledgeSupport 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 releaseParticipate 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 productsProvide manufacturing operations with “on-floor” manufacturing technical supportUtilize concepts of root cause analysis for generation of complete and concise investigation reports resolving quality discrepancies and deviations during GMP production

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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Excellent oral and written communication skillsStrong technical writing ability requiredExcellent interpersonal, teamwork, and leadership skillsMust be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.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 neededMust be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factorsApplied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end productsUnderstanding of new manufacturing technologies including single use disposablesProcess 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.).

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.  Ability to gown and gain entry to controlled manufacturing areas.  Ability to lift, pull or push equipment weighing up to 25-50 lbs.Occasional standing is required 

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.