Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
MBR AUTHOR
(INDUSTRIAL INFORMATION AND OPERATIONS TECHNOLOGY)
Excellent consulting opportunity as full-time employee working 100% remotely, with one visit onsite to California. This role is ideal with a Korber (Werum) PAS|X designer and author for MES (manufacturing execution system). We are looking for tech savvy professionals with a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical manufacturing environments to include cell and gene therapy production. Due to our unique approach in meeting the demands of our customers, we are pursuing both individuals that can join our team long term as well as SMEs (subject matter experts) that would like to join us on a consulting basis.
SUMMARY
The MBR Author will have involvement across various stages of the life cycle including implementation, change management and daily site support. Primary tasks will include but not be limited to the following activities:
- PAS-X MES design, development, documentation, testing and implementation within life sciences (biopharmaceutical) environments.
- Gathering user requirements to map existing or new manufacturing processes to the associated process automation and enterprise level systems.
- Configuring/Developing electronic batch records (EBRs).
- Developing qualification documentation to include performing dry and wet testing of EBRs.
- Supporting the implementation of patches and hotfixes to supported systems.
REQUIREMENTS
- 3+ years of experience within the authoring of MBRs.
- Experience with the implementation and integration of Level 3 & 4 Industrial IT systems such as MES and enterprise level data analytics / management software.
- Werum PAS|X design and authoring experience in GMP environment.
- Up-to-date with new technologies around the IIoT / Digital Transformation space.
- Exposure to cell and gene therapy production, single-use technologies, and IIoT integrated environments is a plus.
- Experience as an end user and/or significant process experience is a plus.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
Top Skills
What We Do
Valspec is the leading provider of computer system validation and system life cycle (SLC) services including the testing, commissioning and qualification of manufacturing automation and IT systems. Valspec was established with a mission to meet the wide spectrum of services that help our clients meet their goals. Our proven history in plant automation and engineering services has allowed us to branch out and be highly effective in meeting a variety of project and resource needs.
We look for passionate engineers like yourself who are looking to:
•Be an innovator
•Work with the best and brightest
•Build the career you want
•Work for a company you can be proud of
Many of the projects that we work on assure that life-changing drugs are available to those who need them. Other projects have a goal of streamlining production to meet demand at a lower cost so that the drug companies have the means to discover new life saving therapies.
