Lediga jobb som Processövervakare, kemisk industri i Sundbyberg

BioLamina is partnering with Hays to recruit a Facility Operations Manager to their headquarters in Sundbyberg

Your new company
BioLamina AB is a Swedish biotechnology company built on a scientific foundation and a legacy in matrix biology and cell culture-based research. Our flagship products, our biorelevant human recombinant laminin isoforms, Biolaminin®, are defined cell culture matrices that successfully imitate the natural, cell-specific cellmatrix interaction in the cell culture dish, allowing cells to thrive and maintain their function. Our products are a powerful resource for scientists working with stem cells and primary cells both within basic research as well as in regenerative medicine companies with a focus on cell therapy applications.
For more information: www.biolamina.com

Your new role
In the role of Facility Operations Manager, you are overall responsible for the facility operations function on the site. Currently, this role is the only one in the function, but as the organization and operations grow, you will likely need to add positions to the function, recruiting new staff that reports to you. You report to the Head of Production, and you are a member of the operational leadership team.
In the role, you will:

* Be the main point of contact for facility related errands with landlord
* Overall responsible of equipment and facility maintenance according to SOP.
* System owner of Utilities systems such as HVAC, gas-station, FMS, water etc.
* Outside office hour on call service
* Manage purchases and installation of necessary equipment, parts, and materials.
* Coordinate new equipment installations, responsible for maintaining compliance with our Quality system.
* Keeping track of service agreements and their associated costs. Follow up costs within budgetary guidelines.
* Contact and price negotiations with equipment maintenance service suppliers.
* Manage contracts for facilities services ensuring supplier compliance.
* Ensuring facility is appropriate for use, and managing changes needed to the facility.
* Ensuring SOPs and lnstructions regarding facility, equipment is in place and up to date. Manage equipment register.
* Assist with on-site inspections and audits from third parties.
* Fire protection officer - ensuring company is compliant to fire safety legislation.
* Collaborate with other departments to provide input on equipment needs and requirements of products. lnitiates, establishes, and maintains effective work relationships with all departments


What you'll need to succeed

* An academic degree (B.Sc. or higher) within Mechanical, Chemical or Electrical Engineering.
* a minimum 5-10 years of corresponding working experience.
* Experience from working in controlled production environment (such as GMP, or similar), with clean room requirements.
* Ability to document requirement specifications and risk analyses.

You will benefit from:

* Independence - being able to drive and deliver in the role based on the set strategy and operational plan.
* Being good at setting requirements,
* Negotiation skills
* Ability to run a cost analysis

as well as:

* A "doer" attitude
* Coordination skills
* Previous experience as a "System owner"
* It is an advantage to understand the basics of a facility monitoring system, as the role will be responsible and primary contact with the supplier.
* Experience from facilities related tasks and responsibilities, and requirements for support systems in a controlled environment (e.g. purified water).

You are likely a generalist with the potential and ambition to develop into a manager position. Maybe you are currently working within facility operations management in a larger organization within the pharma industry and wants a chance to develop and make an larger impact for the organisation?You have a good self-drive and are a team player, able to work and collaborate successfully with different type of people across functions and organizations. You are good at communicating (in both English and Swedish), a good listener, and have a thing for project management.

What you get
This is a great chance for someone with experience from facility operations management from a larger organization to be able to take on a larger scope and more overall responsibility. You will be able to work cross-functionally within a Swedish biotechnology company with exciting products/business, and have an impact on its operations. As the organization and operations grow, you have the chance to grow with it, and develop into a manager position as you start to build a facilities team.

What you need to do now
In this recruitment, BioLamina is partnering with Hays.Applications will be processed as they come, so if you are interested in the role, don't hesitate to submit your application today - click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. Visa mindre

BioProcess Operator
Do you have experience within process industry and want to work with products that can really make a difference in the field of regenerative medicine? Join our production team that produces human recombinant laminins that are sold as a culturing platform for different types of primary cells. The demand for our products is increasing around the world and we therefore need to expand our production team in Sundbyberg, just outside Stockholm. We are looking for a thorough and detail-oriented BioProcess Operator.
RESPONSIBILITES
The Process Operator is part of the Biolamina Production team, responsible for manufacturing (cell vial to finalised & labelled product in vials) of high-quality recombinant proteins according to defined processes (LN and CAP) according to written procedures to fulfill ISO 9001 QMS and applicable laws and regulations.
The process operator participates actively in all areas of production where trained/certified to carry out the tasks, working independently as well as part of a team. Responsible for delegated areas within the overall responsibility of department.
Main tasks
Performing production of recombinant proteins according to written procedures for which training/ certification has been received.
o LN process and CAP process
o upstream and downstream operations, media and buffer preparations
o equipment handling and cleaning
o materials handling
o production and facility support
· Documentation of activities according to QMS by recording events in for example BPRs, logbooks, stock cards as well as reporting of unexpected events in applicable reports.
· Identify/Participate in deviations investigations, CAPA and Change Control activities.
· Update SOPs and BPRs.
· Hold specific responsibilities to manage production system e.g., responsibility of Equiptment according to Equiptment list and FMS on-call responsibility.


REQUIREMENTS
The ideal candidate will have a laboratory science background and/or previous experience of working in the process industry with upstream processing, or equivalent qualification. Experience also from downstream processing is an advantage but not requirement.
Experience of cell culturing is an advantage
Experience in biotechnological production of recombinant proteins, aseptic working technique, cleanrooms is an advantage.
Reliability, interpersonal skills and attention to detail are highly valued
Bachelor's degree within Science, technology, biochemistry is required
Basic office computing skills – Word and Excel
Working according to GMP it is an advantage but not a requirement.
Good knowledge of English both spoken and in writing. Knowledge of Swedish is a plus.

In general
Adhere to relevant safety and quality standards, for process efficency, product safety and operational safety.
Report observations/ deviations within and outside delegated responsibility.
Perform work in compliance with the BioLamina Quality Management System (QMS) and contribute to continuous development of the QMS.
Keep own training and training documentation up to date.
Plan and perform own work in accordance with department prioritisations and goals.
Contribute to continuous development of company and department performance and smooth day- to -day running of the production and well-being of the team.

HOW TO APPLY
Send your application, including CV and Cover Letter, to [email protected]
Placement from earliest August, with reservation of withdrawal depending on forthcoming decisions and planning.
ABOUT BIOLAMINA
BioLamina AB is a Swedish based Biotech company that originates from scientific innovations at Karolinska Institute. Our main products are recombinant laminins, human proteins that are being used to maintain and expand pluripotent stem cells and other primary cell types and for subsequent differentiation into different specialized cell types. BioLamina is revolutionizing cell culture and our products are being used by researchers to develop cellular therapies, building on the era of regenerative medicine. Founded in 2009, BioLamina has grown organically and today we are about 45 employees who develop, produce, market, and sell cell culture research reagents to academic and industrial scientists globally. For more information, please see: http://www.biolamina.com
At BioLamina we are striving to work according to GMP within a few years. The company has a certified quality system according to ISO 9001:2015..
BioLamina is a member of IKEM – Innovation and Chemical Industries in Sweden. IKEM has collective agreements with relevant trade unions of the sector, and as a member Biolamina is fulfilling terms of employment according to collective agreement. Visa mindre