What are the responsibilities and job description for the Engineer III - MTS position at LSNE/PCI Pharma Services?
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.
JOB SUMMARY -
The Manufacturing Science and Technology (MTS) Engineer III is responsible for providing technical leadership in process-related investigations, utilize technical knowledge to effectively support root cause analysis, implementation of process improvements, and improvements in process execution strategies. The group works and collaborates to develop transfer and maintain robust processes, from developmental scale to support clinical and commercial manufacturing operations, including aseptic operations (fill/finish) and medical devices. The department will be a key contributor for performing process improvements, including timely completion of feasibility studies, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products/devices to pre-clinical, clinical and commercial manufacturing phases.
JOB DUTIES -- Actively participate and provide input and feedback for the PCI Safety Program to meet Health and Safety regulations and OSHA requirements in all duties.
- Experimentation and manufacturing support related work including development and pilot scale studies to support process development, optimization and characterization. Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple manufactured products.
- Participate during technology transfer of programs spanning all phases of biopharmaceutical/medical device lifecycle, including discussions of scale, equipment design and oversight of GMP and Engineering batches. Establish technical support initiatives for GMP operations in these multi-product sites.
- Interact with manufacturing operations staff, troubleshoots problems and supports their operations.
- Compose technical documents (protocols, engineering runs, batch records, SOP's) for conducting technical studies
- Determine material requirements for processes and establishing criteria for material acceptance.
- Design/select small scale equipment (typically < 50L) for Client based products brought into LSNE. Collaborate with PCI Engineering department on equipment selection at all scales.
- Function as a technical expert on equipment, systems, processes for tech transfers.
- Collaborate with PCI process development for studies required to establish GMP scale operating conditions and processes.
- Collaborate with PCI validation team related to support of process validation efforts.
- Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.
- Execute tasks, under the minimal direction of project managers or MTS management, to complete design, engineering, and documentation support for technical transfer and process improvement projects within schedule and budget constraints.
- Provide technical support to external clients and internal operations, utilizing statistical data analysis.
- Develop solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives.
- Drives key equipment, systems, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule and overall project performance.
- Provide technical input for product tech transfers, evaluation of process requirements versus facility capabilities.
- Provide technical support and analysis for the resolution of deviations, investigations, and process issues.
- Works independently to develop department procedures, standards, and specifications Writing and reviewing data summaries as per established company guidelines and procedures.
- Authors technical reports, technology transfer packages and presentations. Drive to present technical accomplishments at Technical Conferences.
- Excellent oral and written communication skills
- Strong technical writing ability required
- Excellent interpersonal, teamwork, and leadership skills
- *Strong skills in data analytics and modeling methods and relevant software
- *Must 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 needed
*Familiarity with the operation and design of small and large scale disposable technologies, traditional 316L sanitary stainless steel equipment (cleaning, sterilization methods), and experience with operation of high vacuum processing equipment used in drying unit operations is high preferred.
*Hands-on experience at Laboratory, pilot or manufacturing scale.
*Strong experience in one or more areas of process development, process transfer, process scale-up and validation activities.
*Knowledge of operations and equipment that support GMP operations (autoclaves, CIP/SIP, washers, depyrogenation, gamma irradiation).
EDUCATION -*BS degree in an Engineering discipline with preference for Chemical of Life Sciences with 10 years industry experience within apharmaceutical, biotechnology/medical device or FDA/ISO regulated industry. Comparable blends of education and experience is acceptable.
QUALITIES -- Resilient, can quickly move forward despite challenges.
- Results driven, with a positive attitude, professional, independent thinker and a team player.
- Honesty, integrity, respect and courtesy with leadership and peers
- Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
TRAVEL - <10%
Join us and be part of building the bridge between life changing therapies and patients.
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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.