Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.
Johnson & Johnson
BE - Engineer 3
Job is closed
Job ID:
JJJP00012305
Location
Geel
Hours/week
40 hrs/week
Timeline
1 year
Starts: Jan 2, 2023
Ends: Dec 24, 2023
Payrate range
Unknown
Application Deadline: Jan 2, 2023 12:00 PM
TechOPs Engineer
The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on:??
· New Product Introduction (NPI) / Life Cycle Management (LCM)?
· Process Validation/Verification??
· Process improvements
· Standards and new technology deployment (e.g. PAT, spray drying, digitalization, ?)??
The Technical Operations (TO) Engineer reports to one of following 4 Technical Operations team leads: NPI lead, LCM lead, spray drying lead, digitalization lead.?
The TO Engineer is a key contributor to NPI / LCM, process improvement initiatives and technology deployment on the site. The level of contribution in these areas and the complexity of the assigned projects is dependent on the education and/or experience level of the engineer and is reflected in the seniority title: regular, senior, staff, principal or senior principal engineer
Main duties:
Manage Product?life cycle / LCM portfolio?
· Partnering with Operations on Project Oversight of projects assigned as well as day to day support (e.g., investigations, escalations).?
· Partnering with Value Stream Lead and BUs on project priorities.
· Monitor process and product performance, based on Continuous Process Verification (CPV)?
· Review / approve Product Quality Reviews (PQR)?
· Lead or support complex process investigations or product related technical issues (escalation of quality or compliance events)?
· Process LCM documentation (including validation protocols and reports, criticality analysis documents, change control)
· The TO engineer can also take the role of an API Technical Owner or Focused Factory Lead or member, both leading or active participating a multi-disciplinary synthesis experts team (the former focussing on long term E2E strategy of the assigned products, the latter on door-to-door robust flow a product or technology.
Knowledge:
1. Specific knowledge and performance:?
· Strong expertise on API manufacturing processes??
· Strong knowledge in the area of validation?
· Strong expertise in Small Molecule API business?
· Project management (FPX), organizing, planning and coordination skills?
· Process excellence (JJPS), lean concepts and tools?
· Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP) and EH&S:?
o Adhere to applicable cGxP?s and procedures?
o Report incidents and deviations?
o Propose solution to improve compliance with cGMP?s?
o Adhere to applicable EH&S and procedures
o Correct use of the available personal and collective protection materials
o Reporting of (near) accidents, incidents, deviations. Act when violation of EH&S rules is observed and stimulate appropriate behaviour?
o Cooperate on and suggest solutions to improve EH&S
o Actively participate in PHA/HAZOP meetings providing process expertise?
2. Personal and interpersonal skills??
· Ability to manage complexity and change?
· Ability to interact at different levels of the organization?
· Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly?
· Ability to create a result oriented (project) team ? for those engineers leading projects?
· Customer and business focus?
Degree
Master?s Degree or PhD in Chemical engineering or process technology (bioscience Engineering, industrial engineering or chemistry), or proven record in an industrial, operational environment.
The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on:??
· New Product Introduction (NPI) / Life Cycle Management (LCM)?
· Process Validation/Verification??
· Process improvements
· Standards and new technology deployment (e.g. PAT, spray drying, digitalization, ?)??
The Technical Operations (TO) Engineer reports to one of following 4 Technical Operations team leads: NPI lead, LCM lead, spray drying lead, digitalization lead.?
The TO Engineer is a key contributor to NPI / LCM, process improvement initiatives and technology deployment on the site. The level of contribution in these areas and the complexity of the assigned projects is dependent on the education and/or experience level of the engineer and is reflected in the seniority title: regular, senior, staff, principal or senior principal engineer
Main duties:
Manage Product?life cycle / LCM portfolio?
· Partnering with Operations on Project Oversight of projects assigned as well as day to day support (e.g., investigations, escalations).?
· Partnering with Value Stream Lead and BUs on project priorities.
· Monitor process and product performance, based on Continuous Process Verification (CPV)?
· Review / approve Product Quality Reviews (PQR)?
· Lead or support complex process investigations or product related technical issues (escalation of quality or compliance events)?
· Process LCM documentation (including validation protocols and reports, criticality analysis documents, change control)
· The TO engineer can also take the role of an API Technical Owner or Focused Factory Lead or member, both leading or active participating a multi-disciplinary synthesis experts team (the former focussing on long term E2E strategy of the assigned products, the latter on door-to-door robust flow a product or technology.
Knowledge:
1. Specific knowledge and performance:?
· Strong expertise on API manufacturing processes??
· Strong knowledge in the area of validation?
· Strong expertise in Small Molecule API business?
· Project management (FPX), organizing, planning and coordination skills?
· Process excellence (JJPS), lean concepts and tools?
· Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP) and EH&S:?
o Adhere to applicable cGxP?s and procedures?
o Report incidents and deviations?
o Propose solution to improve compliance with cGMP?s?
o Adhere to applicable EH&S and procedures
o Correct use of the available personal and collective protection materials
o Reporting of (near) accidents, incidents, deviations. Act when violation of EH&S rules is observed and stimulate appropriate behaviour?
o Cooperate on and suggest solutions to improve EH&S
o Actively participate in PHA/HAZOP meetings providing process expertise?
2. Personal and interpersonal skills??
· Ability to manage complexity and change?
· Ability to interact at different levels of the organization?
· Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly?
· Ability to create a result oriented (project) team ? for those engineers leading projects?
· Customer and business focus?
Degree
Master?s Degree or PhD in Chemical engineering or process technology (bioscience Engineering, industrial engineering or chemistry), or proven record in an industrial, operational environment.
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