JMD Technologies Inc.
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Execute
aseptic process simulations (APS)
and support
process validation
activities, including documentation, execution, and result review.
Develop and author
validation protocols
such as URS, IQ, OQ, and PQ in alignment with
GDP
and
GMP
standards.
Perform
equipment and analytical instrument qualification
following regulatory and internal guidelines.
Conduct
automation and software compliance assessments
to ensure adherence to
21 CFR Part 11
requirements.
Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete
CQV (Commissioning, Qualification & Validation)
tasks.
Support validation of
automated manufacturing systems
and sterile process controls.
Maintain accurate, audit-ready
validation documentation
in compliance with quality system requirements.
Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek.
Ensure all work aligns with applicable SOPs, regulations, and
Good Documentation Practices (GDP) .
Seniority Level: Mid-Senior level
Employment Type: Contract
Job Function: Information Technology, Telecommunications
Referrals increase your chances of interviewing at JMD Technologies Inc. by 2x
Get notified about new Validation Engineer jobs in
Boston, MA .
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Execute
aseptic process simulations (APS)
and support
process validation
activities, including documentation, execution, and result review.
Develop and author
validation protocols
such as URS, IQ, OQ, and PQ in alignment with
GDP
and
GMP
standards.
Perform
equipment and analytical instrument qualification
following regulatory and internal guidelines.
Conduct
automation and software compliance assessments
to ensure adherence to
21 CFR Part 11
requirements.
Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete
CQV (Commissioning, Qualification & Validation)
tasks.
Support validation of
automated manufacturing systems
and sterile process controls.
Maintain accurate, audit-ready
validation documentation
in compliance with quality system requirements.
Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek.
Ensure all work aligns with applicable SOPs, regulations, and
Good Documentation Practices (GDP) .
Seniority Level: Mid-Senior level
Employment Type: Contract
Job Function: Information Technology, Telecommunications
Referrals increase your chances of interviewing at JMD Technologies Inc. by 2x
Get notified about new Validation Engineer jobs in
Boston, MA .
#J-18808-Ljbffr