drjobs Process Owner Lead

Process Owner Lead

Employer Active

1 Vacancy
The job posting is outdated and position may be filled
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Jobs by Experience drjobs

5years

Job Location drjobs

Dublin - Ireland

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description


About PSC Biotech



Who we are


PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.



Take your Career to a new Level


PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.



Employee Value Proposition


Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.



An exciting and rare opportunity has presented for a Process Owner (Specialist Manufacturing) Lead. This is a senior role in the organization and requires indepth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation Formulation Syringe Filling Vial Filling Lyophilisation and Capping.

As a Process Owner Lead you will be an established professional who is a selfstarter capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts who wants to be challenged and can lead change from a manufacturing operations perspective.

Supporting key areas of the business the Process Owner Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to daytoday support related to unplanned event troubleshooting investigations CAPA identification and implementation.




Requirements


Primary responsibilities:

Perform as a knowledgeable subject matter expert (SME) and single point of contact on site and network projects and programs to advance manufacturing and aseptic operations through ownership of the assigned processes and taking a proactive approach to safety quality and compliance by actively seeking opportunities to remove error traps.

Accountable for process documentation (e.g. SOPs Training Electronic Batch Records Risk Assessments) in assigned area of responsibility. Gatekeeper (develop review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process.

Leading and/or providing input to strategic initiatives that will improve and develop processes for the future.

Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required.

Use subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met challenges identified mitigations are in place and communication plans delivered to all stakeholders.

Involved in the daily business management systems and reporting have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.

Lead and/or Support investigations that impact on safety quality and/or compliance of the processes ensuring thorough investigations are conducted and actionable CAPAs to prevent future reoccurrence are implemented within agreed timeline.

Remain current on stateoftheart for systems and processes and advise on the appropriate adoption and use of new techniques and technology.

Ability to lead change from an aseptic operations perspective is a plus.


What you need to apply:

Bachelor s degree in science Engineering or related discipline with 5 years experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience.

Experience with regulatory compliance in cGMP manufacturing and indepth knowledge of Eudralex Volume 4 Annex 1 Manufacture of Sterile Medicinal Products.

Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner.

Excellent DecisionMaking skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area.

Proactive and works well with others in a collaborative fastpaced goaldriven environment.

Interacts well with diverse groups (Manufacturing Validation Engineering Quality etc) and maintains strong working relationships with internal and external collaborators.

Demonstrated ability to coach mentor and/or cross train colleagues within core technical areas.

Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations procedures change controls) and good Presentation skills.



#LIAP1


Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following: Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping. Key contributor to product and process investigations, responsible for assessing product and process impact. Leads continuous improvement projects to improve process performance and productivity. The chosen candidate would typically be involved in activities such as (but not exclusively); Assess product impact associated with proposed changes to commercial processes under the change control process. Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support. Review and approve changes to operating procedures, electronic batch records, and product documentation. Risk assessments and mitigation projects relating to line performance. Perform process gap analysis and developing strategies to close gaps. Data trend analysis for all performance aspects of the area. Troubleshooting performance trends. Basic Qualifications: Bachelor s or master s degree in engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience. Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. Preferred Qualifications: Typically, 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation Qualification in Lean and 6-sigma methodologies would be an advantage. New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous. #LI-AP1

Employment Type

Full Time

Company Industry

Pharma / Biotech / Clinical Research

About Company

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.