Manufacturing Tech Lead
Company: Yoh, A Day & Zimmermann Company
Location: Amherst
Posted on: February 25, 2021
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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
#ZipSPG
#LI-PC1
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
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