Process Technician

RESPONSIBILITIES:

- Responsible for execution of the manufacturing process as well as the "first-line" technical support within their assigned Asset Group. (cross function, across assets, site tech services, EVM, etc.)
- Drives continuous improvement efforts cross- functionally.
- Uses operations knowledge and technical knowledge to lead troubleshooting activities, lead tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement process improvements.
- Collaborate, coach and develop technical skill (engineering, science principles).
- Develop and present comprehensive Technical presentations.
- Communicate and resolve operational variances.
- Execute routine manufacturing activities including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review, and special sample coordination.
- Serve as the "acting" People Leader in the absence of the shift's People Leader, including promoting a safety and innovation culture.
- Process monitoring including Real Time review of process parameters and process data/trend analysis.
- Communicate process performance across shifts and departments.
- Implement process enhancements, measures and respond to equipment capability and implement new technologies.
- Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables, site assessments, review and approve plant documentation, change controls, process overview presentations, sampling plans, and other tech transfer deliverables.
- Author, review and approval documentation such as batch records, CAPAs, procedures policy and instructions, validation reports, automation tables.
- Provide input, review and approval for investigations, commitments, and change controls assuring changes provide robust equipment and enhanced capability - ensures changes are value added.
- Provide support during audits and with audit observation closure.
- Perform skills training and provide subject matter expertise to training materials.
- Collaborate cross-functionally to resolve issues and drive improvement with MSAT, STS, EVM, etc.
- Promotes a culture of innovation and continuous improvement.
- Drives changes that supports efficiency and/or reduced costs.
- Collaborates with Operations Services to develop programs and strategies for Real Time process monitoring.

SKILLS

Process GMP operation skills in Fermentation, Cell Culture or Purification. troubleshooting ability, Automation, Data Analysis, engineering skills required. A minimum of a BS in Engineering or Life Science is required. Manufacturing, Biopharmaceutical required. Qualifications include a willingness to work in a challenging environment that requires execution of new processes or stable processes. Effective verbal and written communication skills. Ability to work with intra and inter departmental functional areas fostering a collaborative teamwork environment is necessary. Works well in a team environment, open minded and flexible, even keeled, energetic, likes to solve problems. Experience in a biopharmaceutical environment of ? 2 years of is preferred. Knowledge of cGMP, cell cultivation techniques, cell separation operation with TFF and/or centrifugation, column purification/membrane based operations, and equipment IQ, OQ, PQ approaches are desirable. Mechanical aptitude is a plus, as many operations require manual intervention as well as use of automation. Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.

Synectics is an Equal Opportunity Employer.