An amazing opportunity, due to promotion, has arisen for a ?SENIOR
BIOPROCESS ASSOCIATE (DOWNSTREAM) . This position will be responsible
for all procedures and processes associated with the Manufacture of
Commercial Large-Scale Drug Substance at our Biologics site in Swords.
WHAT YOU WILL DO:
Bring energy, knowledge, innovation and leadership to carry out the
following:
* Work with the manufacturing operations group, project design team,
the CQV team, the Automation/CSV reps to facilitate the development
and validation of the Biotech facility manufacturing facility.
* Support Equipment Design/ HAZOP and Room programming reviews as
per requirements.
* Support Operations team to consistently deliver on specific area
Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan,
OEE, compliance and team training.
* Execute commercial manufacturing processes according to
established work instructions and Standard Operating Procedures.
* Work as part of a dedicated process team where flexibility and
teamwork are a key requirement
* Generate SOPS/Electronic Batch Records for start-up.
* Provide assistance and/or support maintenance, engineering,
quality or other colleagues as requested.
* Escalate issues as appropriate.
* Maintain a high level of personal expertise and working knowledge
of all aspects of the manufacturing process and process equipment
through continuous training and development.
* Liaise with other groups and individuals to ensure planning of
tasks is effective and linked into the manufacturing process plan.
WHAT SKILLS YOU WILL NEED:
In order to excel in this role, you will more than likely have:
* Degree qualification (Science/Quality/Technical).
* **Apply on the website**years experience
* Preference Lean Six Sigma
* Experience in a highly regulated drug substance manufacturing
environment is essential.
* Start-up experience in a large scale commercial drug substance
facility desirable but not essential.
* Excellent understanding of Upstream Processing
* Ability to work as part of a team and on own initiative in a
constructive manner.
As a company, we are committed to ?Inventing for Life? in all that
we do. We keep the patient at the very heart of all that we do and
strive to find solutions and treatments for some of the world?s most
challenging healthcare needs.
We are proud to be a company that embraces the value of bringing
diverse, talented, and committed people together. The fastest way to
breakthrough innovation is when diverse ideas come together in an
inclusive environment.
SO, IF YOU ARE READY TO:
Invent solutions to meet unmet healthcare needs, Impact the future by
driving one of the world?s leading healthcare companies, and inspire
your team to reach their full potential and push the boundaries of
science and technology, PLEASE APPLY TODAY.
SEARCH FIRM REPRESENTATIVES PLEASE READ CAREFULLY
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp &
Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited
assistance from search firms for employment opportunities. All CVs /
resumes submitted by search firms to any employee at our company
without a valid written search agreement in place for this position
will be deemed the sole property of our company. No fee will be paid
in the event a candidate is hired by our company as a result of an
agency referral where no pre-existing agreement is in place. Where
agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
EMPLOYEE STATUS:
Regular
RELOCATION:
No relocation
VISA SPONSORSHIP:
TRAVEL REQUIREMENTS:
FLEXIBLE WORK ARRANGEMENTS:
SHIFT:
1st - Day, 3rd - Night
VALID DRIVING LICENSE:
HAZARDOUS MATERIAL(S):
JOB DESCRIPTION
An amazing opportunity, due to promotion, has arisen for a ?SENIOR
BIOPROCESS ASSOCIATE (DOWNSTREAM) . This position will be responsible
for all procedures and processes associated with the Manufacture of
Commercial Large-Scale Drug Substance at our Biologics site in Swords.
WHAT YOU WILL DO:
Bring energy, knowledge, innovation and leadership to carry out the
following:
* Work with the manufacturing operations group, project design team,
the CQV team, the Automation/CSV reps to facilitate the development
and validation of the Biotech facility manufacturing facility.
* Support Equipment Design/ HAZOP and Room programming reviews as
per requirements.
* Support Operations team to consistently deliver on specific area
Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan,
OEE, compliance and team training.
* Execute commercial manufacturing processes according to
established work instructions and Standard Operating Procedures.
* Work as part of a dedicated process team where flexibility and
teamwork are a key requirement
* Generate SOPS/Electronic Batch Records for start-up.
* Provide assistance and/or support maintenance, engineering,
quality or other colleagues as requested.
* Escalate issues as appropriate.
* Maintain a high level of personal expertise and working knowledge
of all aspects of the manufacturing process and process equipment
through continuous training and development.
* Liaise with other groups and individuals to ensure planning of
tasks is effective and linked into the manufacturing process plan.
WHAT SKILLS YOU WILL NEED:
In order to excel in this role, you will more than likely have:
* Degree qualification (Science/Quality/Technical).
* **Apply on the website**years experience
* Preference Lean Six Sigma
* Experience in a highly regulated drug substance manufacturing
environment is essential.
* Start-up experience in a large scale commercial drug substance
facility desirable but not essential.
* Excellent understanding of Upstream Processing
* Ability to work as part of a team and on own initiative in a
constructive manner.
As a company, we are committed to ?Inventing for Life? in all that
we do. We keep the patient at the very heart of all that we do and
strive to find solutions and treatments for some of the world?s most
challenging healthcare needs.
We are proud to be a company that embraces the value of bringing
diverse, talented, and committed people together. The fastest way to
breakthrough innovation is when diverse ideas come together in an
inclusive environment.
SO, IF YOU ARE READY TO:
Invent solutions to meet unmet healthcare needs, Impact the future by
driving one of the world?s leading healthcare companies, and inspire
your team to reach their full potential and push the boundaries of
science and technology, PLEASE APPLY TODAY.
SEARCH FIRM REPRESENTATIVES PLEASE READ CAREFULLY
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp &
Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited
assistance from search firms for employment opportunities. All CVs /
resumes submitted by search firms to any employee at our company
without a valid written search agreement in place for this position
will be deemed the sole property of our company. No fee will be paid
in the event a candidate is hired by our company as a result of an
agency referral where no pre-existing agreement is in place. Where
agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
EMPLOYEE STATUS:
Regular
RELOCATION:
No relocation
VISA SPONSORSHIP:
TRAVEL REQUIREMENTS:
FLEXIBLE WORK ARRANGEMENTS:
SHIFT:
1st - Day, 3rd - Night
VALID DRIVING LICENSE:
HAZARDOUS MATERIAL(S):
We need : English (Good)
Type: Permanent
Payment:
Category: Others
