Automation Engineer II
Company: UMass Biologics
Location: Mattapan
Posted on: January 27, 2023
Job Description:
Automation Engineer II
Minimum Salary
US-MA-Mattapan
Job Location
2 weeks ago(1/9/2023 4:06 PM)
Requisition Number
2022-42203
# of Openings
1
Posted Date
Day
Shift
Exempt
Overview
GENERAL SUMMARY OF POSITION: The cGxP Automation Engineer II
supports all of the Automation systems in an FDA regulated research
and manufacturing environment. Ensures all automation systems are
maintained through proper cGMP change management procedures.
Troubleshoots automation performance issues. Recommends upgrades,
patches, and new applications and equipment. Provides technical
support and guidance to users. Ensures that MBL's Automation
solutions are consistent with organizational goals, industry best
practices, and regulatory requirements, including but not limited
to cGxP and 21 CFR part 11.
Responsibilities
MAJOR RESPONSIBILITIES:
- Develops, programs, monitors, tests,
reports on and maintains GMP and non GMP Automation systems.
Assists with the creation of design changes when necessary.
Compiles performances statistics and reports as needed.
- Exercises independent judgment within scope of authority. When
necessary, escalates issues to appropriate authority level to
ensure prompt and appropriate resolution within the context of
organizational priorities.
- Assists with data backup procedures and disaster recovery
strategy of automation systems.
- Makes recommendations with respect to the procurement of
Automation related hardware and software in a cGxP
environment.
- Proposes IS solutions based on SME documented user needs.
Obtains ratification to prioritize and implement IS solutions.
Performs automation related improvements, upgrades and repairs as
necessary.
- Provides timely and appropriate automation related support and
training to end users.
- Performs risk and vulnerability assessments, including
automation system audits. Develops plans to anticipate and prevent
potential automation failures and resolves any automation related
failures that arise.
- Executes testing, qualifications, and validations to ensure
consistent functionality and cGxP compliance.
- Performs electronic and paper documentation relevant to areas
of responsibility. Writes cGxP documentation such as SOPs, change
controls, incidents and deviations, planned deviations, and
installation qualifications. Ensures documentation complies with
cGxP and other applicable regulations.
- Supports projects and operations at MBL's Mattapan and
SouthCoast facilities.
- Maintains up to date knowledge of industry trends and best
practices.
- Maintains effective communication and relationships internally
and externally to MBL.
- Performs additional duties as required.
Qualifications
- Requires a bachelor's degree in Engineering or related field
(mechanical engineering preferred) with a minimum 2 years of
relevant experience or equivalent combination of education and
experience
- Requires knowledge of LAN, WLAN, WAN IP routing, network
security, network management, process automation (SCADA, PLC's,
HMI's) and building management and building security systems
- Prior experience in a cGxP regulated environment. Strong
working knowledge of cGxP, 21CFR part 11, and MA data security
regulations
- Ability to follow instructions precisely , recognize
deviations, and recommend corrective action
- Demonstrated ability to train others
- Ability to conduct complex troubleshooting
- Computer literate and proficient in MS Word, Excel and other
relevant electronic systems
- Strong critical thinking, time management and organizational
skills. Demonstrated ability to multitask and consistently meet
deadlines
- Possesses well developed attention to detail, ability to
maintain accurate records and excellent proofreading skills.
- Excellent written and verbal communication skills. Ability to
communicate effectively (up, down, and laterally) with others
- Demonstrated initiative through past experience
- Ability to work effectively both independently and as a member
of a team
- Occasional travel may be required
- Ability to work flexible and, at times extended hours to meet
the business needs of a 24 / 7 / 365 manufacturing operation
- Ability to routinely lift up to 50 lbs using proper lifting
technique (monitors, servers, switches)
Keywords: UMass Biologics, Boston , Automation Engineer II, Engineering , Mattapan, Massachusetts
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