Manufacturing Tech Lead

Company: Yoh, A Day & Zimmermann Company
Location: Amherst
Posted on: February 25, 2021

Job Description:

Lead Manufacturing Tech (cGMP, ISO, Formulation, Fill/ Finish, Aseptic Processing)


JOB SUMMARY

Performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ ISO requirement and standards. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, dissolution and formulation activities. Will be required to train and lead in this role.




JOB DUTIES


Assist with the formulation and validation of new processes with the assistance of the tech transfer group
Oversight and execution of all routine and critical operations as well as commissioning and validation activities, as assigned. Revise and author Standard Operating Procedures/Batch Records
Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.). Ensure sanitization and sterilization practices (build, clean, sanitize and sterilize equipment and components to support production operations
Perform and ensure COP, CIP, and SIP operations are performed to prepare equipment





Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations. Responsible for floor inventory and communicating schedule changes as needed to supervisor
Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
Maintain and adhere to safe work habits and all applicable safety procedures and guidelines
Execute manufacturing instructions in order to perform equipment preparation, compounding, filtration, formulation and fill activities for aseptic and terminally sterilized products in accordance with SOPs
Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation
Communicate/ coordinate days scheduling and staffing plan with supervisor
Recommend/Implement process changes/improvements or safety/ergonomic improvements
Provide timely feedback on staff's performance and address minor personnel issues in a timely manner
Ensure staff compliance with all relevant SOPs, BR, and safety guidelines
Perform room sanitization activities in order to maintain controlled environment conditions
Conduct training and assess effectiveness and help identify training needs
Assess staff skillsets and provide feedback to Supervisor. Assist in developing training material and provide training to operators. Act as a role model (Lead by Example) and a resource/SME for staff
Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause and implement appropriate corrective actions
Assist Supervisor/Engineer/Facilities with investigations and communicate any quality issues/concerns to Supervisor and QA. Interacts with cross functional support teams, such as Quality Assurance (QA), Quality Control (QC) Engineering, R&D, Validation, etc.
Ensure general knowledge of aseptic techniques and maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique





EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE


High School Diploma; Minimum 5 years professional and FDA Regulated industries experience; Pharmaceutical or Medical Device experience with 3 years in lead role
Associates Degree in Life Sciences/Engineering field with a minimum of 5 years of GMP Manufacturing Pharmaceutical or Medical Device Experience
Biotech Certificate or Associates degree with 5 years of experience in a cGXP/ ISO environment, or Bachelor's degree in a scientific discipline, Biology, Chemistry, or Biotechnology with 3 -5 years of experience in a lead role preferred
Familiarity with Formulation, Filling and primary Packaging and Aseptic Processing
Strong knowledge of aseptic techniques preferred
Flexible individual with good written and verbal communication skills
Excellent communication and organizational skills
Experience in reviewing and creating controlled documents.
MS Office/Excel tools experience
Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor, they are the person of authority
Attention to detail with strong mechanical aptitude
Positive attitude and strong interpersonal skills


Keywords


Inventory Management
Manufacturing
Good Manufacturing Practice (GMP)
Standard Operating Procedure (SOP)
Process Equipment
Process Improvement









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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic.Category: Manufacturing, Keywords: Manufacturing Manager

Keywords: Yoh, A Day & Zimmermann Company, New England , Manufacturing Tech Lead, Other , Amherst, Northeast