Job Details: Technical Operations Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Technical Operations Specialist
_JOHNSON & JOHNSON WORKSENSE (VIA RANDSTAD SOURCERIGHT) IS RESPONSIBLE
FOR FINDING, ENGAGING AND CONTRACTING TALENT FOR THE JOHNSON & JOHNSON
CONTINGENT WORKFORCE._

We have an exciting contract opportunity for a TECHNICAL OPERATIONS
SPECIALIST to join our expanding team in Janssen, Cork to help support
the Technical Operations unit. This contract is starting ASAP until
**Apply on the website** st December **Apply on the website**
initially. Our ideal candidate will have at least **Apply on the
website** months post graduate experience within Validation preferably
in Bio.

As TECHNICAL OPERATIONS SPECIALIST, you will be responsible for the
active engagement with the Technical Operations team, delivering a
successful outcome to all Technical Operations activities using Good
Manufacturing Practices (GMP). These activities include, but are not
limited to; Cleaning Validation, Autoclave Load Qualification and
Validation, Process Validation Support (e.g. Mixing Studies, Media
Challenge), Change Control, GMP documentation generation (e.g.
protocols / SOPs / WIs / Technical Documents, Exception/Event
Investigations/Closure.

As a TECHNICAL OPERATIONS SPECIALIST, your typical day may include:

* Conduct Technical Operations activities in compliance with US and
EU regulations, JSI procedures and EHS&S requirements.
* Develop Technical Operations documentation as required (e.g.
strategies, plans, protocols, procedures, reports).
* Review and approve documents prepared by other Technical
Operations colleagues.
* Execute Technical Operations protocols as required.
* Compile relevant documentation from contractors, suppliers, and
other departments for inclusion in reports.
* Prepare reports for executed protocols for review and approval.
* Initiate and implement change control activities in accordance
with site procedures.
* Track and resolve exceptions/events/deviations during Technical
Operations activities.
* Prioritize Technical Operations activities in line with the
project schedule.
* Co-ordinate Technical Operations activities with contractors and
vendors as required.
* Co-ordinate Technical Operations document review and approval.
* Collate and organize Technical Operations files for turnover to
QADC.
* Attend identified training, required to fulfill the role of a
Technical Operations Specialist.
* Participate in cross-functional teams as required.

EXPERIENCE:

* Educated to Bachelor&#**Apply on the website**;s Degree in a
scientific/technical discipline required
* Focus on patients and customers at all times
* Experience in Validation (e.g. Performance Qualification (e.g.
Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies,
Media Challenge), Cleaning Validation, Process Validation)
* Knowledgeable of FDA/EMEA regulatory requirements applicable to
biologics and/or pharmaceuticals. Ability to apply cGMP regulations
and guidelines to all aspects of Technical Operations activities
* Demonstrated knowledge and application of industry regulations
including those of FDA, HPRA, EMEA and other authorities

WHAT YOU&#**APPLY ON THE WEBSITE**;RE GREAT AT:

* Excellent interpersonal skills
* Ability to operate as part of a team is critical.
* Customer focus
* Innovative
* Excellent communication skills both written and verbal
* Attention to detail
* Good problem-solving skills
* Results and performance driven
* Adaptable and flexible
* Integrity, trustworthiness and objectivity
* Knowledgeable of FDA/EMEA regulatory requirements

WHAT YOU GET IN RETURN:

* Flexible working hours across a **Apply on the website** hour week
* Opportunity to work with a leading company in advanced science
* Excellent rates of pay depending on experience

_JOHNSON & JOHNSON WORKSENSE (VIA RANDSTAD SOURCERIGHT) IS RESPONSIBLE
FOR FINDING, ENGAGING AND CONTRACTING TALENT FOR THE JOHNSON & JOHNSON
CONTINGENT WORKFORCE._

We have an exciting contract opportunity for a TECHNICAL OPERATIONS
SPECIALIST to join our expanding team in Janssen, Cork to help support
the Technical Operations unit. This contract is starting ASAP until
**Apply on the website** st December **Apply on the website**
initially. Our ideal candidate will have at least **Apply on the
website** months post graduate experience within Validation preferably
in Bio.

As TECHNICAL OPERATIONS SPECIALIST, you will be responsible for the
active engagement with the Technical Operations team, delivering a
successful outcome to all Technical Operations activities using Good
Manufacturing Practices (GMP). These activities include, but are not
limited to; Cleaning Validation, Autoclave Load Qualification and
Validation, Process Validation Support (e.g. Mixing Studies, Media
Challenge), Change Control, GMP documentation generation (e.g.
protocols / SOPs / WIs / Technical Documents, Exception/Event
Investigations/Closure.

As a TECHNICAL OPERATIONS SPECIALIST, your typical day may include:

* Conduct Technical Operations activities in compliance with US and
EU regulations, JSI procedures and EHS&S requirements.
* Develop Technical Operations documentation as required (e.g.
strategies, plans, protocols, procedures, reports).
* Review and approve documents prepared by other Technical
Operations colleagues.
* Execute Technical Operations protocols as required.
* Compile relevant documentation from contractors, suppliers, and
other departments for inclusion in reports.
* Prepare reports for executed protocols for review and approval.
* Initiate and implement change control activities in accordance
with site procedures.
* Track and resolve exceptions/events/deviations during Technical
Operations activities.
* Prioritize Technical Operations activities in line with the
project schedule.
* Co-ordinate Technical Operations activities with contractors and
vendors as required.
* Co-ordinate Technical Operations document review and approval.
* Collate and organize Technical Operations files for turnover to
QADC.
* Attend identified training, required to fulfill the role of a
Technical Operations Specialist.
* Participate in cross-functional teams as required.

EXPERIENCE:

* Educated to Bachelor&#**Apply on the website**;s Degree in a
scientific/technical discipline required
* Focus on patients and customers at all times
* Experience in Validation (e.g. Performance Qualification (e.g.
Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies,
Media Challenge), Cleaning Validation, Process Validation)
* Knowledgeable of FDA/EMEA regulatory requirements applicable to
biologics and/or pharmaceuticals. Ability to apply cGMP regulations
and guidelines to all aspects of Technical Operations activities
* Demonstrated knowledge and application of industry regulations
including those of FDA, HPRA, EMEA and other authorities

WHAT YOU&#**APPLY ON THE WEBSITE**;RE GREAT AT:

* Excellent interpersonal skills
* Ability to operate as part of a team is critical.
* Customer focus
* Innovative
* Excellent communication skills both written and verbal
* Attention to detail
* Good problem-solving skills
* Results and performance driven
* Adaptable and flexible
* Integrity, trustworthiness and objectivity
* Knowledgeable of FDA/EMEA regulatory requirements

WHAT YOU GET IN RETURN:

* Flexible working hours across a **Apply on the website** hour week
* Opportunity to work with a leading company in advanced science
* Excellent rates of pay depending on experience



We need : English (Good)

Type: Permanent
Payment:
Category: Others

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