Manufacturing Specialist (Investigative)
Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this Manufacturing Investigative Specialist role could be an ideal opportunity to explore.
As a Manufacturing Investigative Specialist you will report into the Specialist team, the role will assist with execution of the production schedule by troubleshooting and remediating operational and process issues, executing root cause investigations, owning/authoring deviations and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records. Initiates Quality Records and conducts deviation investigations.
Leads or assists in investigations including root cause analysis and assesses product impact using input from various departments
Develops, executes and oversees CAPAs
Supports Tech transfer and process monitoring support as needed
Works with the team to monitor critical process parameters
Revision and management of manufacturing documents such as Batch Records and SOPs
Leads or supports Continuous Improvement projects
Conducts data gathering, trending, and data presentation as needed to support investigations
Supports Manufacturing coordination efforts such as sampling, equipment modification and
maintenance, and internal inspection activities to ensure minimal interruption to routine operations
Assists with shutdown/changeover and campaign scheduling and schedule management
Support internal and external audits as needed
Why you?Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BA / BS in a scientific or technical discipline, and 2+ years of
- demonstrated technical competency in biopharmaceutical manufacturing
- Previous experience in a biopharmaceutical manufacturing facility
- (operations experience preferred)
- Previous experience in production control systems (Delta-V ,
- CCDARTS, Unicorn, or similar)
- Previous experience in process deviation investigations and
- Previous experience authoring and/or revising technical documents
- Knowledge of cGMP requirements and practices and previous
- experience in a cGMP setting
If you have the following characteristics, it would be a plus:
- Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans
- on time and on budget
- Excellent communication and technical writing skills
- Ability to support and/or lead system troubleshooting efforts
- Initiates change control for equipment modifications
- Assist with coordination of cleaning validation and verification activities in the manufacturing areas to
- ensure minimal interruption to routine operations
- Assist in development, execution and reporting of data from biopharmaceutical technology and tech
- transfer studies/protocols
- Participate in cross-functional teams to solve production problems
- Must be willing to work shifts
- Ability to collect, assess, and generate and depict conclusions from large quantities of production data
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Back to top